Clinical trial NCT02583399
Conditions: Pain Fever
Keywords: Pediatric (Birth to less than 6 months of age) Pain Fever
Sponsor: Cumberland Pharmaceuticals
Start date: 2017-08-08; Completion date: 2019-07-02
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Detailed description:
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Arms: arm 1: Ibuprofen, 10 mg/kg
Interventions: intervention 1: Ibuprofen
Intervention descriptions: intervention 1: Ibuprofen, 10 mg/kg

Protocol documents:
Prot_000.pdf: 
IND 062605 
5.3.3.5 Clinical Study Protocol
Cumberland Pharmaceuticals Inc. 
CALDOLOR® (ibuprofen) Injection
CPI-CL-022; Amendment 02 
Page 1 
CLINICAL STUDY PROTOCOL 
A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction 
in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six 
Months 
Study Number: CPI-CL-022 
ClinicalTrials.gov ID: NCT02583399
Protocol Version 
Version Number:  
Original Protocol 
Final:  
 
01Jun2015 
Amendment:   
Amendment 02 
Revised Final: 
30Sep2016 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by 
applicable laws and regulations. In any event, persons to whom the information is disclosed must 
be informed that the information is privileged or confidential and may not be further disclosed by 
them. These restrictions on disclosure will apply equally to all future information supplied to you 
which is indicated as privileged or confidential. 


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RESPONSIBLE PERSONNEL 
Sponsor - Medically Responsible Person 
 Sponsor’s Coordinating Office 
 
  
 
 
 
Director, Medical Affairs 
 Sr. Vice President & Chief Development 
Officer 
Cumberland Pharmaceuticals Inc. 
 Cumberland Pharmaceuticals Inc. 
2525 West End Avenue, Suite 950 
 2525 West End Avenue, Suite 950 
Nashville, TN 37203 
 Nashville, TN 37203 
USA 
 USA 
 
  
Tel.: 
  
 Tel.: 
  
Fax.: 
 
 Fax.: 
 
 
 
 
 
  
Sponsor’s Clinical Operations  
  
 
  
 
  
Sr. Manager, Clinical Operations 
  
 
  
 
  
 
  
Cumberland Pharmaceuticals Inc. 
  
2525 West End Avenue, Suite 950 
  
Nashville, TN 37203 
  
USA 
  
 
  
Tel.: 
  
  
Fax.: 
 
  
 
 
 


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1 
INVESTIGATOR’S STATEMENT 
I have read and agree to the Protocol CPI-CL-022, Amendment 02: “A Multi-Center, Open-Label 
Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric 
Subjects Aged Birth to Six Months.” I am aware of my responsibilities as an Investigator under 
the guidelines of Good Clinical Practice (GCP), local regulations (as applicable) and the study 
protocol.  I agree to conduct the study according to these guidelines and to appropriately direct 
and assist the staff under my control, who will be involved in the study. 
Principal Investigator 
Signature: 
 
 
 
 
 
 
Date of Signature 
Name: 
 
Title: 
 
Address: 
 
Telephone: 
 
 
 
 
 
 
Sponsor Signature 
Signature: 
 
 
 
 
Date of Signature 
 
Director, Medical Affairs  
 
 
 
 
Signature: 
 
 
 
 
Date of Signature 
 
Senior Vice President & Chief Development Officer 
 
 


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SYNOPSIS 
Name of Sponsor: 
Cumberland Pharmaceuticals Inc. 
Finished Product: 
CALDOLOR® 
(ibuprofen) 
injection 
Active Ingredient: 
ibuprofen 
Title of Study: 
A Multi-Center, Open-Label, Pharmacokinetic, and Safety Study for Reduction in Fever or 
Management of Pain in Pediatric Subjects Aged Birth to Six Months 
Study Centers (Planned): 
Approximately 5 centers in the United States 
Expected Study Duration:  
From Q3 2016 to Q3 2017 
Phase of Development: 
IV 
Objectives: 
Primary Study Objective 
• To determine the pharmacokinetic (PK) profile of intravenous ibuprofen administered over 
approximately 10 minutes in hospitalized pediatric subjects, aged birth (> 37 weeks 
gestational age) to < 6 months of age. 
Secondary Study Objectives 
• To determine the safety of single and repeated doses of intravenous ibuprofen administered in 
hospitalized pediatric subjects, aged birth (> 37 weeks gestational age) to < 6 months of age, 
with a clinical indication of pain and fever by assessing treatment–emergent adverse events 
(AE) and changes in vital signs (temperature, heart rate [HR], respiratory rate [RR], and 
systolic and diastolic blood pressures. 
Methodology: 
This is a multi-center, open-label, in-patient, single and/or multiple dose study in pediatric 
subject, aged birth (> 37 weeks gestational age) to < 6 months of age, with a clinical indication of 
pain and fever. Subjects who meet all of the inclusion and none of the exclusion criteria at the end 
of the Screening/Baseline Period are eligible to be enrolled into the study.  
 
Assessments of vital signs and pain scores, if appropriate, will be conducted at baseline and at 
regular intervals when investigational medicinal product (IMP) dosing occurs. Pharmacokinetic 
blood samples will be done with the initial dose of IMP to determine plasma ibuprofen 
concentration in all subject’s dosed with IMP. Blood samples for safety assessments including 
clinical chemistry, hematology, and coagulopathy, will be done at screening and on Study Days 1 
and 2. Adverse event monitoring will occur throughout the study period. The study duration will 
be 72 hours.  
Number of subjects (planned): 
Twenty-four 
Diagnosis and main criteria for inclusion: 
A subject must have met the following inclusion criteria:  
1. Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < 
six months of age.  
2. Have a clinical indication of pain or fever. 
3. Have written informed consent provided by legal parent, guardian, or authorized agent 
prior to participation in the study or performance of any study-only related procedures. 


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Name of Sponsor: 
Cumberland Pharmaceuticals Inc. 
Finished Product: 
CALDOLOR® 
(ibuprofen) 
injection 
Active Ingredient: 
ibuprofen 
Investigational Medicinal Product (IMP), dose and mode of administration, batch number: 
• Intravenous ibuprofen, 10 mg/kg, intravenous.  
Duration of treatment: 
48 hours 
Criteria for evaluation: 
The primary objective of this study is to evaluate the PK profile of a single dose of intravenous 
ibuprofen administered over approximately 10 minutes.  
The secondary objective of this study is to evaluate the safety of single and repeated doses of 
intravenous ibuprofen administered to hospitalized pediatric patients by assessing treatment-
emergent adverse events, vital signs, and laboratory assessments 
Statistical methods: 
Continuous data will be summarized in tables listing the mean, standard deviation or standard 
error. All data will be listed by patient. Safety will be evaluated on the basis of vital signs and 
treatment-emergent AEs. AE data will be listed individually and summarized by body system 
organ class and preferred terms within system organ class (MedDRA).  Serious and/or unexpected 
AEs will also be discussed on a case-by-case basis. On the basis of plasma ibuprofen 
concentration-time data, PK parameters will be estimated by using a non-compartmental model. 
 


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TABLE OF CONTENTS 
1 
INVESTIGATOR’S STATEMENT ............................................................................. 3 
2 
SYNOPSIS .................................................................................................................. 4 
3 
TABLE OF CONTENTS ............................................................................................. 6 
4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ................................. 9 
5 
INTRODUCTION ......................................................................................................11 
5.1 
Background Information ........................................................................................11 
5.2 
Stage of Development ............................................................................................11 
5.3 
Patient Population .................................................................................................. 14 
5.4 
Trial Rationale ....................................................................................................... 14 
5.5 
Risk-Benefit Assessment ....................................................................................... 14 
5.5.1 
Risk –Benefits Associated with Therapeutic Procedures .................................. 14 
5.5.2 
Risk–Benefits Associated with Non-Therapeutic Procedures ........................... 16 
5.5.3 
Risk to Confidentiality ...................................................................................... 16 
6 
STUDY OBJECTIVES AND PURPOSE .................................................................. 16 
7 
STUDY ENDPOINTS ............................................................................................... 17 
7.1 
Primary Study Endpoints ....................................................................................... 17 
7.2 
Safety Endpoints .................................................................................................... 17 
8 
STUDY DESCRIPTION ........................................................................................... 17 
8.1 
Study Design.......................................................................................................... 17 
8.1.1 
Randomization ................................................................................................... 19 
8.1.2 
Blinding Conditions and Methods ..................................................................... 19 
8.1.3 
Pharmacokinetics ............................................................................................... 20 
8.2 
Drugs and Dosages ................................................................................................ 20 
8.2.1 
Identification and Description of Test Agents ................................................... 20 
8.2.2 
Dosing Instructions and Schedule ..................................................................... 20 
8.2.3 
Accountability Procedures for Investigational Medicinal Product.................... 22 
8.3 
Selection of Study Population ............................................................................... 23 


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8.3.1 
Inclusion Criteria ............................................................................................... 23 
8.3.2 
Exclusion Criteria .............................................................................................. 23 
8.4 
Prior and Concomitant Therapy ............................................................................ 23 
8.4.1 
Excluded Medications/Procedures/Therapy ...................................................... 24 
9 
EXPERIMENTAL PROCEDURES .......................................................................... 24 
9.1 
Overview – Schedule of Time and Events ............................................................ 24 
9.2 
Measurements and Evaluations ............................................................................. 25 
9.2.1 
Screening/Baseline Period ................................................................................. 25 
9.2.2 
Treatment Period (Study Hour 0 to Study Hour 48) .......................................... 26 
9.2.3 
Post-treatment Period (Study Hour 48 to Study Hour 72) ................................. 28 
10 
SUBJECT DISCONTINUATION ............................................................................. 29 
10.1 
Circumstances for Subject Discontinuation .......................................................... 29 
10.2 
Procedures for Subject Discontinuation ................................................................ 30 
11 
Study or Site Termination .......................................................................................... 30 
12 
ADVERSE EVENTS................................................................................................. 31 
12.1 
Definitions ............................................................................................................. 31 
12.2 
Collection, Recording and Reporting of Adverse Events ...................................... 33 
12.3 
Follow-up of Adverse Events ................................................................................ 33 
13 
STATISTICAL METHODS AND DATA ANALYSIS .............................................. 34 
13.1 
General Overview .................................................................................................. 34 
13.2 
Populations of Interest ........................................................................................... 34 
13.3 
Baseline Comparability ......................................................................................... 34 
13.4 
Safety Analysis ...................................................................................................... 34 
13.5 
PK Analysis ........................................................................................................... 35 
13.6 
Interim Analysis ..................................................................................................... 35 
13.7 
Sample Size Determination ................................................................................... 35 
14 
STUDY MANAGEMENT AND DATA COLLECTION .......................................... 35 
14.1 
Confidentiality ....................................................................................................... 35 


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14.2 
Source Documents ................................................................................................. 36 
14.3 
Case Report Forms ................................................................................................ 36 
14.4 
Study Files ............................................................................................................. 36 
14.5 
Records Retention ................................................................................................. 37 
15 
STUDY MONITORING, AUDITING, AND INSPECTING .................................... 37 
15.1 
Study Monitoring Plan........................................................................................... 37 
15.2 
Quality Control and Quality Assurance ................................................................. 37 
16 
ETHICAL CONSIDERATIONS ............................................................................... 38 
16.1 
Informed Consent .................................................................................................. 38 
16.2 
Protocol Compliance ............................................................................................. 38 
17 
REFERENCES .......................................................................................................... 39 
18 
APPENDICES ........................................................................................................... 39 
18.1 
Responsibilities and Obligations of Investigators and Sponsors ........................... 39 
18.1.1 
Sponsor .............................................................................................................. 39 
18.1.2 
Investigator ........................................................................................................ 40 
 
List of Tables 
Table 5–1 
CALDOLOR® (ibuprofen) Injection Clinical Studies .......................................... 12 
Table 8–1 
Overall Schedule of Time and Events ................................................................... 19 
Table 8-2 
Selected Inducers and Inhibitors of CYP2C9 ....................................................... 24 
 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
AE 
Adverse Event/Experience 
AUC 
Area Under the Curve 
C 
Celsius 
CABG 
Coronary Artery Bypass Surgery 
CHD 
Congenital Heart Disease 
CM 
Clinical Monitor 
CRF 
Case Report Form 
Cmax 
Maximum concentration 
Ct 
Last Measurable Ibuprofen Concentration 
DCF 
Data Clarification Form 
F 
Fahrenheit 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability and Accountability Act 
HR 
Heart rate 
ICH 
International Conference on Harmonization  
IEC 
Independent Ethics Committee 
IMP 
Investigational Medicinal Product 
IRB 
Institutional Review Board 
IV 
Intravenous 
kg 
Kilogram 
λ 
Terminal elimination rate constant 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mL 
Milliliter 
N 
NS 
Number of Subjects 
Normal Saline 
NSAID 
Nonsteroidal anti-inflammatory drug  
OTC 
Over the Counter 
PRN 
pro re nata (as necessary) 
PK 
Pharmacokinetics 
RR 
Respiratory rate 
SAE 
Serious Adverse Event/Experience 


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Abbreviation 
Definition 
T1/2 
Half-life 
Tmax 
Time to maximum concentration 
US 
United States 
 


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5 
INTRODUCTION 
This study is to be performed in accordance with Good Clinical Practice (GCP), the ethical 
principles that have their origin in the Declaration of Helsinki, Title 21 of the Code of Federal 
Regulations Parts 50, 56, and 312 and the International Conference on Harmonization (ICH) E6. 
5.1 
Background Information 
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that was first approved for 
marketing as a prescription drug in the United States (US) in 1974. Oral ibuprofen is currently 
approved for use as oral treatment for minimal to moderate pain from arthritis, surgery, sunburn, 
menstruation, and fever. Like aspirin and other drugs in the NSAID family, ibuprofen is believed 
to reduce the inflammatory response by inhibiting the formation of prostaglandins. Several 
studies have demonstrated the success of oral or rectal ibuprofen in the reduction of fever and the 
subjective symptoms associated with it (Schwartz 1999, Krishna 1995). 
In 1989, the US Food and Drug Administration (FDA) approved ibuprofen for use in children. 
Approval for marketing pediatric ibuprofen as an over-the-counter product in the United States 
was granted in the mid-1990s, and today it is one of the most commonly used antipyretic and 
analgesic therapies in children. Oral ibuprofen is commonly used in hospitals to treat patients 
with pain and fever. However, hospitalized patients with endotracheal intubation, sedation, 
reduced gastric motility, nausea, recent surgery, or other factors are frequently unable to ingest, 
digest, absorb, or tolerate oral medications. 
CALDOLOR® (ibuprofen) Injection was approved by the US Food and Drug Administration in 
June 2009 for adults and in May 2016 for pediatric patient greater than six months of age. 
CALDOLOR is indicated in adults and pediatric patients 6 months and older for the management 
of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid 
analgesics and for the reduction of fever. This formulation of intravenous (IV) ibuprofen is now 
being studied for use in the pediatric population less than 6 months of age. 
5.2 
Stage of Development  
This is a phase 4 study to determine the pharmacokinetics (PK) and safety of single and/or 
multiple doses of intravenous ibuprofen administered over 10 minutes in children less than six 
months of age. This study will investigate the application of intravenous ibuprofen in the 
treatment of pain and/or fever.   
To date, sixteen clinical studies have been conducted in adult and pediatric subjects with 
intravenous ibuprofen. Of the 16 completed studies (Number of Subjects [N] = 2107), three 


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provide PK data associated with various infusion times, three provide efficacy and safety data 
supporting use for temperature reduction in febrile adult patients, three provide efficacy and 
safety data supporting use for treatment of moderate to severe pain as an adjunct to opioid 
analgesics in adult patients undergoing elective abdominal and orthopedic surgeries, one study 
provides pilot data for temperature reduction in febrile pediatric patients, one study provides PK, 
safety, and efficacy data supporting use for temperature reduction in hospitalized febrile pediatric 
subjects, one study provides efficacy and safety data supporting use for pain as an adjunct to 
opioid analgesics in pediatric patients undergoing elective tonsillectomy surgery, two studies 
provide safety data supporting a shortened infusion time, and two studies assesses the analgesic 
efficacy of IV ibuprofen when administered at induction of anesthesia compared to IV ketorolac. 
Table 5-1 lists the completed intravenous ibuprofen studies.  
Table 5–1 
CALDOLOR® (ibuprofen) Injection Clinical Studies 
Study 
Number  
Title  
N  
Indication  
CPI-CL-001  
A 
Phase 
l, 
Open-Label, 
Randomized, 
Single-Dose, 
Crossover, 
Pharmacokinetic, and Safety Study with Intravenous and Oral Ibuprofen in 
Healthy Subjects  
36  
PK, Safety  
CPI-CL-003  
A 
Randomized, 
Double-Blind, 
Placebo-Controlled, 
Multiple-Dose, 
Crossover Study of the Safety and Tolerability of Ibuprofen Injection in 
Healthy Adult Subjects  
12  
PK, Safety, 
Tolerability 
CPI-CL-004  
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled 
Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Ibuprofen 
Injection in Adult Febrile Patients  
120  Fever  
CPI-CL-005  
A Multi-Center, Randomized, Parallel, Open-Label, Active-Controlled 
Efficacy and Safety Study of Ibuprofen Injection in Hospitalized Febrile 
Pediatric Patients  
30  
Fever  
CPI-CL-006  
A Single Center, Randomized, Double-Blind, Placebo-Controlled Trial to 
Evaluate the Efficacy and Safety of Ibuprofen Injection in Hospitalized 
Febrile Adult Patients  
60  
Fever  
CPI-CL-
008A  
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of 
Ibuprofen Injection for Treatment of Pain in Post-Operative Adult Patients, 
Dose-Ranging  
406  Pain  
CPI-CP-008B  A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of 
Ibuprofen Injection for Treatment of Pain in Post-Operative Adult Patients, 
Abdominal  
319  Pain  
CPI-CL-008C  A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of 
Ibuprofen Injection for Treatment of Pain in Post-Operative Adult Patients, 
Orthopedic  
185  Pain  
CPI-CL-010  
A Multicenter, Randomized, Double-blind Trial of Ibuprofen Injection 
(IVIb) for Treatment of Fever and Pain in Burn Patients  
61  
Fever, Pain 
CPI-CL-011  
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and 
Tolerability of Ibuprofen Injection in Healthy Adult Volunteers  
11  
PK, Safety, 
Tolerability 
CPI-CL-012 
A Multi-Center, Randomized, Open-Label, Parallel, Active-Comparator 
Trial to Determine the Efficacy, Safety, and Pharmacokinetics of 
Intravenous Ibuprofen in Pediatric Patients 
103 
Fever 
CPI-CL-014 
A Multi-Center, Randomized, Double-blind Placebo-Controlled, Single-
Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for 
161 
Pain 


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Study 
Number  
Title  
N  
Indication  
Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy 
CPI-CL-015 
A Multi-Center, Open-Label, Surveillance Trial to Evaluate the Safety and 
Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen 
150 
Pain, Fever 
CPI-CL-016 
A Multi-Center, Open-Label, Surgical Surveillance Trial to Evaluate the 
Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen 
300 
Pain 
CPI-CL-017 
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain 
Control Following Arthroscopic Knee Surgery 
53 
Pain 
CPI-CL-020 
A Multicenter, Prospective, Randomized, Double-blind Study to Determine 
the Efficacy of Intravenous Ibuprofen compared to Intravenous Ketorolac 
for Pain Control Following Arthroscopic Knee Surgery 
100 
Pain 
IVIb = Ibuprofen Injection, N= Number of Subjects, PK = Pharmacokinetics 
 
Please refer to the Investigator’s Brochure for additional detail surrounding these studies. 
To date, three studies have been conducted utilizing intravenous ibuprofen in pediatric subjects. 
A pediatric fever trial (CPI-CL-005) was conducted in 30 subjects to assess the efficacy and 
safety of intravenous ibuprofen in pediatric subjects with fevers greater than or equal to 101.0ºF 
(Fahrenheit) (38.3ºCelsius [C]). The mean age for all patients was 6.19 (± 3.67) years. Age 
ranged from a minimum of 0.5 to a maximum of 17 years. The primary endpoint of the study 
was to determine the clinical equivalence of a single dose of intravenous ibuprofen compared to 
acetaminophen for the treatment of fever as measured by the area under the temperature versus 
time curve (AUC-Tº) within the first six hours of treatment (as compared to a target temperature 
of 98.6ºF [37.0ºC]). Both treatments demonstrated a statistically significant reduction in fever, 
with intravenous ibuprofen reducing fever more in the first two hours. While the two treatments 
were not shown to be equivalent with respect to the primary endpoint, the study was 
underpowered to demonstrate equivalence. 
A pediatric fever trial (CPI-CL-012) was conducted in 103 subjects to assess the efficacy, safety, 
and PKs of intravenous ibuprofen in pediatric subjects less than or equal to sixteen years of age 
with fevers greater than or equal to 101.0ºF (38.3ºC). The mean age for all patients was 7 (± 4.5) 
years. The primary endpoint of the study was to determine the superiority of a single dose of 
intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the 
area under the change in temperature versus time curve during the first 2 hours of treatment 
(AUC0-2). Compared to acetaminophen, patients receiving 10 milligram/kilogram (mg/kg) 
intravenous ibuprofen experienced a significant reduction in fever as measured by the area under 
the curve 0-2 hours and 0-4 hours). 
A pediatric pain trial (CPI-CL-014) was conducted in 161 subjects to assess the efficacy and 
safety of intravenous ibuprofen in pediatric subjects undergoing tonsillectomy. The mean age for 
all patients was 9 (± 3.2) years. The primary endpoint of the study was to evaluate the efficacy of 


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a single preemptive dose on reducing the number of doses of fentanyl administered in the 
postoperative period to discharge. Compared to placebo there was a significant reduction in post-
operative fentanyl use during the post-operative period. In addition to using less fentanyl, 
subjects experienced a significant reduction in the incidence of vomiting and emesis following 
discharge.  
5.3 
Patient Population 
The population for this study will consist of hospitalized pediatric subjects from birth (> 37 
weeks gestational age) to < 6 months of age with a clinical indication of pain and/or fever.   
5.4 
Trial Rationale 
For the pediatric patient population, there are multiple oral over-the-counter (OTC) ibuprofen 
products available for the treatment of pain in children.  Motrin® (McNeil Consumer Healthcare, 
Fort Washington, Pennsylvania) is one of the most commonly used oral ibuprofen products 
currently marketed. The recommended dose for Motrin for treatment of pain in children 6 
months to 12 years of age is 10 mg/kg with the recommended maximum daily dose of 40 mg/kg. 
The recommended dosing for children 12 years of age and older is the same as that used for 
adults, 200 to 800 mg up to four times daily, with a maximum of 3200 mg per day.  
Based on the approved dosing for the product in pediatric patients greater than 6 months, as well 
as published results from clinical studies, the dose selected for this study is 10.0 mg/kg of 
intravenous ibuprofen. The total daily dose should not exceed 40 mg/kg/day. 
5.5 
Risk-Benefit Assessment 
5.5.1 
Risk –Benefits Associated with Therapeutic Procedures 
Risk-Benefits of Intravenous Ibuprofen Administration 
The study is an open label design and therefore all subjects enrolled into the trial will receive 
ibuprofen. Ibuprofen is a widely prescribed medication in children greater than 6 months of age 
and in adults. It is commonly prescribed as a treatment for pain and fever. Inclusion into the trial 
is limited to subjects who have a clinical indication of pain and/or fever that would be treated 
with ibuprofen.  
Intravenous ibuprofen is contraindicated in subjects with a known hypersensitivity (e.g., 
anaphylactoid reactions and serious skin reactions) to ibuprofen or other NSAIDs; in subjects 
who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or 


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NSAIDs; and for use during the peri-operative period in the setting of coronary artery bypass 
surgery (CABG).  
Ibuprofen is contraindicated in newborn infants with uncorrected ductus dependent congenital 
heart disease (CHD) including ductus dependent systemic blood flow lesions (aortic 
stenosis/critical aortic stenosis, coarctation of aorta, interrupted aortic arch, and hypoplastic left 
heart syndrome) and ductus dependent pulmonary blood flow lesions (critical pulmonary 
stenosis, pulmonary atresia, pulmonary atresia with intact ventricular septum (hypoplastic right 
heart syndrome), tricuspid atresia with severe pulmonary stenosis, tetralogy of fallot with 
pulmonary atresia, Ebstein’s anomaly, transposition of the great arteries with intact ventricular 
septum).  
The most common adverse events, occurring in the pediatric clinical trials, experienced by 3% or 
more subjects were alanine aminotransferase increased, anemia, aspartate aminotransferase 
increased, blood lactate dehydrogenase increased, basophilia, diarrhea, eosinophilia, headache, 
hypokalemia, infusion site pain, neutropenia, pruritus, nausea, and vomiting.  
Risk of Laboratory Assessments 
The study involves both therapeutic and non-therapeutic blood draws. The laboratory 
assessments are therapeutic as the results may provide a direct benefit to the subject by providing 
health status information that may not have been otherwise obtained if the subject was not in the 
study. The risks of taking blood includes pain, bruising at the point where the blood is taken, 
redness and swelling of the vein, infection, and a rare risk of fainting. The risk associated with 
the blood draws can be decreased by utilizing standard of care laboratory results as opposed to 
study specific laboratory sample collection when possible; by the use of indwelling venous 
and/or arterial catheters to collect blood samples, when possible; by utilizing heel sticks if 
deemed appropriate by the investigator, and, by utilizing the smallest amount of blood necessary 
to complete the required procedures.  
Risk-Benefits of other Therapeutic Procedures 
To ensure the safety of the subject, vital signs will be monitored using the standard measurement 
devices located at each clinical center. Vital signs, especially blood pressure, should be 
performed utilizing clinical center standard of care age appropriate devices (i.e. automated blood 
pressure cuff measurements or indwelling blood pressure measurement devices are preferred to 
manual cuff measurements; unless personnel performing the manual blood pressure 
measurement is specifically training to perform the measurement in this age population). 
Laboratory testing will be monitored for changes in chemistry, hematologic, and coagulation 
measurements.     


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5.5.2 
Risk–Benefits Associated with Non-Therapeutic Procedures 
Risk of PK Assessments 
The study involves both therapeutic and non-therapeutic blood draws. The laboratory 
assessments are therapeutic as the results provide a direct benefit to the subject by providing 
health status information that may not have been otherwise collected if the subject was not in the 
study. The PK sampling however would be considered non-therapeutic because they resultant 
data will not provide a direct benefit to the study subject; instead, these data will allow for the 
further understanding, prevention, or alleviation of a serious problem affecting the health or 
welfare of children. The risks of both the therapeutic and non-therapeutic blood draws are 
similar. The risks of taking blood includes pain, bruising at the point where the blood is taken, 
redness and swelling of the vein, infection, and a rare risk of fainting. The risk associated with 
the blood draws can be decreased by utilizing standard of care laboratory results as opposed to 
study specific laboratory sample collection when possible; by the use of indwelling venous 
and/or arterial catheters to collect blood samples, when possible; by utilizing heel sticks if 
deemed appropriate by the investigator, and, by utilizing the smallest amount of blood necessary 
to complete the required procedures.  
5.5.3 
Risk to Confidentiality 
The study has been designed to minimize the need to collect identifiable data by determining 
whether there is a legitimate reason to collect or maintain identifiable data. All sponsor 
maintained study records will identify the subject by their screening number if the subject is not 
enrolled and dosed with the Investigational Medicinal Product (IMP) in the trial and by the 
subject number if the subject is enrolled and dosed with IMP in the trial. Clinical Center Team 
Member are instructed to de-identify/redact any record that are provided to the sponsor and 
identify necessary documents by the subject’s randomization number. In addition to minimizing 
data collection, each subject’s parent or legal guardian will be asked to review and sign the 
Clinical Center’s IRB approved consent and or independent Health Information Portability and 
Accountability Act (HIPAA) confidentiality agreement.        
6 
STUDY OBJECTIVES AND PURPOSE 
The primary objective of this study is to evaluate the PK profile of a single dose of intravenous 
ibuprofen administered over approximately 10 minutes.   
The secondary objectives of this study are: 


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• to evaluate the safety of single and repeated doses of intravenous ibuprofen administered 
to hospitalized pediatric patients by assessing treatment-emergent adverse events, vital 
signs, and laboratory assessments 
7 
STUDY ENDPOINTS 
7.1 
Primary Study Endpoints 
To evaluate the primary objective of PKs, the following endpoint will be measured:  
• Clearance 
• Volume of distribution 
• Elimination T1/2 
• Cmax,  
• AUC(0-∞, 0-t) 
7.2 
Safety Endpoints 
To evaluate safety, the following endpoints will be measured: 
• Treatment emergent adverse events 
• Vital signs (temperature, heart rate, respiratory rate, blood pressure) 
• Clinical chemistry, hematology, and coagulation assessments  
8 
STUDY DESCRIPTION 
8.1 
Study Design 
This multi-center, open-label, single and/or multiple dose clinical study will assess the PKs 
(following a single dose) and safety during and after the administration of intravenous ibuprofen. 
A total of twenty-four subjects, between the ages of birth (> 37 weeks gestational age) to less 
than six months of age, will be enrolled at up to five clinical centers. The study duration will be 
up to 72 hours.  
This 72 hour study will consist of a Screening/Baseline Period (up to 48 hours prior to the first 
dose of IMP), a Treatment Period (beginning with the first dose of IMP and continuing for 48 
hours) and a Post-Treatment Period (beginning at the end of the Treatment Period and continuing 
for 24 hours). 


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The Screening/Baseline Period may begin up to 48 hours prior to Study Hour 0. During the 
Screening/Baseline Period an evaluation of the inclusion and exclusion criteria, a complete 
medical history, and a physical examination will be conducted. A review of the subject’s pre- 
IMP vital signs, baseline signs and symptoms, including pain scores (if applicable), concomitant 
medications, and laboratory assessments will be also conducted to establish the subject’s 
eligibility to participate in the study.  
The Treatment Period will begin at Hour 0 when an initial dose of investigational medicinal 
product will be administered over a 10 minute period. Subsequent doses of IMP will be 
administered, at the investigators discretion, every 6 to 8 hours, as needed, during the 48 hour 
treatment period. The total daily dose should not exceed 40 mg/kg/day. Pharmacokinetic 
sampling will be performed utilizing a sparse sampling technique following the initial dose of 
IMP. Vital signs, pain scores (if applicable), laboratory assessments and concomitant medications 
will be monitored during the treatment period and adverse events (AEs) will be monitored during 
the treatment and post-treatment periods. All treatment emergent adverse events will be followed 
until resolution or stabilization, regardless of the assessment of severity or relationship to the 
study drug. 
The Schedule of Time and Events is provided in Table 8-1.  


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Table 8–1 
Overall Schedule of Time and Events 
 
Measurement/Evaluation 
Study Period 
Screening/ 
Baseline 
 
Treatment 
Post-
Treatment 
 
Time(s) 
Hour - 48 to 
Hour 0 
Hour 0 to 
Hour 24 
Hour 24 to 
Hour 48 
Hour 48 to 
Hour 72 
Informed Consent 
X 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
Medical History 
X 
 
 
 
Physical Examination 
X 
 
 
 
Demographic Data 
X 
 
 
 
Baseline Signs & Symptoms 
X 
 
 
 
Vital Signs 
X 
X 
X 
Xꬸ 
Laboratory Assessments 
X* 
Xˢ 
 
Xꬸ 
Pharmacokinetic Assessments 
 
Xφ 
 
 
Concomitant Medications 
X+ 
X 
X 
 
IMP Administration (Initial & PRN) 
 
X 
X 
 
Adverse Event Monitoring 
 
X** 
X** 
X** 
IMP = Investigational Medicinal Product  
* Laboratory data collected within 48 hours prior to dosing may be used for Screening/Baseline Period laboratory 
assessments.  
+ Record concomitant medication actually administered to the subject in the 8 hours prior to the first dose of IMP. 
φ PK assessment must be taken immediately following the first dose of IMP then per the sparse sampling schedule.  
ˢ Laboratory Assessment must be performed at Study Hour 24 (± 6 hours)  
ꬸLaboratory Assessment and Vital Signs must be performed at Study Hour 72 (± 6 hours) or at the time of discharge, 
whichever occur first.  
**All treatment adverse events will be followed until resolution or stabilization, regardless of the assessment of 
severity or relationship to the study drug. 
 
8.1.1 
Randomization 
All subjects who meet all the inclusion and exclusion criteria during the Screening/Baseline 
Period will be enrolled into the study. Only eligible subjects will be assigned to receive 
intravenous ibuprofen, 10 mg/kg per dose.  
There is no randomization; this study is open-label with respect to the treatment assignment. 
8.1.2 
Blinding Conditions and Methods 
This study is open-label with respect to the treatment assignment. All study personnel, sponsor, 
research team, and subject’s parent or legal guardian are unblinded to the treatment assignment. 


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8.1.3 
 Pharmacokinetics 
Pharmacokinetic parameters, including clearance, volume of distribution, elimination T1/2, Cmax, 
and AUC, will be determined from analysis of collected blood samples (Section 13.5). One 
milliliter (mL) samples for PK analysis will be collected at specified times on all subjects. The 
PK profile of intravenous ibuprofen for the study will be completed utilizing sparse sampling 
techniques.  
PK samples will be collected on all subjects immediately (± 5 minutes) following completion of 
the first dose of intravenous ibuprofen; then alternating subjects will have PK sampling 
performed at 30 minutes and 2 hours or at 1 hour and 4 hours following the first dose of 
intravenous ibuprofen (12 subjects will have samples collected immediately following the first 
dose, then at 30 minutes and 2 hours; and, 12 subjects will have samples collected immediately 
following the first dose, then at 1 hour and 4 hours).  
Pharmacokinetic sampling will only be performed following the first dose of IMP regardless of 
the total number of doses of IMP administered. Sites will be notified by the sponsor of which PK 
samples to be collected.    
8.2 
Drugs and Dosages 
8.2.1 
Identification and Description of Test Agents 
Intravenous ibuprofen is available for investigation use only in the pediatric population.  
Intravenous ibuprofen is packaged as a clear, colorless liquid in 10 mL glass vials, each 
containing 800 mg ibuprofen in a total of 8 mL (100 mg/mL). Each vial also contains 
approximately 78 mg/mL arginine.   
Normal saline (NS), which will be supplied by each site, will be used as the diluent for 
intravenous ibuprofen in this study. 
All investigational materials should be kept in a secured area inaccessible to unauthorized 
individuals. A Study Procedures Manual will be provided to the sites documenting the IMP 
storage and preparation procedures.  
8.2.2 
Dosing Instructions and Schedule 
The dose in this study was selected using the results generated from three previous clinical 
studies in pediatric subjects conducted by Cumberland and by the current recommended 
available dosing information (Taketomo 2003). 


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Commercially available drug product will be provided to the site pharmacist in an unblinded 
fashion. The pharmacist will prepare each dose of the intravenous ibuprofen for the subject by 
adding weight appropriate amounts of ibuprofen to NS. The addition of the ibuprofen will be 
done directly to commercially available bags of NS. Each dose of intravenous ibuprofen will be 
prepared at a concentration of 4 mg/mL or less. 
The vials of Intravenous ibuprofen will contain information on the label providing name of 
product, strength, and storage conditions: 
• 
 CALDOLOR® (Ibuprofen) injection 
• 
800 mg/8 mL (100 mg/mL) 
• 
FOR INTRAVENOUS USE 
• 
Store at controlled room temperature 
• 
20ºC -25ºC (68ºF-77ºF) 
• 
Manufactured for: Cumberland Pharmaceutical Inc. Nashville, TN 37203 
Labels for Intravenous ibuprofen infusion bags will include the information listed above as well 
as the patient identification number and protocol number. 
An initial dose of 10 mg/kg intravenous ibuprofen administered intravenously over 10 minutes 
will be administered. Following the initial dose, subsequent doses of IMP may be administered 
every 6-8 hours as needed, at the investigator’s discretion, during the 48 hour Treatment Period. 
The maximum daily dose of intravenous ibuprofen will not exceed 40 mg/kg/day. A total of up to 
eight doses of IMP may be administered during the 48 hour Treatment Period.  
With each dose of IMP, the intravenous catheter should be flushed with NS before and after each 
infusion. The intravenous catheter can be used for other infusions during the Treatment Period if 
it is adequately flushed. If a central venous catheter is available, that route of administration is 
preferred; however, a peripheral intravenous line with good blood return is also acceptable. A 
dedicated line is not required. 
The Study Procedures Manual will contain directions for the preparation of intravenous 
ibuprofen by the pharmacist.  


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8.2.3 
Accountability 
Procedures 
for 
Investigational 
Medicinal 
Product 
All IMP shipments should be inspected upon receipt. Any discrepancy, breakage or unacceptable 
temperature condition should be reported immediately to the sponsor. If the shipment is 
acceptable, the site pharmacist or their designee will sign and date the packing slip and file the 
original form in the pharmacy study binder.  Receipt of IMP shipments must be documented on 
the appropriate Pharmacy Accountability Record. 
IMP inventory and accountability records for the study drug will be kept by the 
investigator/pharmacist. IMP accountability throughout the study must be documented. The 
following guidelines are pertinent:  
• The investigator agrees not to supply study drugs to any persons except the subjects in 
this study. 
• The pharmacist will keep the study drug in a pharmacy or other locked and secure storage 
facility under controlled storage conditions, accessible only to those authorized by the 
investigator to dispense these test drugs.  
• A study drug inventory will be maintained by the pharmacist. The inventory will include 
details of material received and a clear record of when they were dispensed and to which 
subject. Intravenous ibuprofen vials should be saved for the duration of the study.  Upon 
completion of IMP preparation, the pharmacist should tally and reconcile the number of 
vials used per patient with the Pharmacy Accountability Record. The used vials should be 
retained until the end of the study. It is not necessary to retain empty infusion bags. 
• Upon conclusion of the study trial, all unused intravenous ibuprofen will be inventoried 
by the Clinical Monitor and packaged for return to the Sponsor or their designee. The 
Clinical Monitor will review all worksheets and Investigational Product inventory logs.  
Used vials of intravenous ibuprofen will be retained and provided to the Clinical Monitor 
to complete the accountability procedures. Following drug shipment and use 
accountability reconciliation the Clinical Monitor will instruct the Clinical Center 
regarding disposal of the IMP and pharmacy supplies at the site close-out visit. It must be 
possible to reconcile delivery records with those of used and returned medication. Any 
discrepancies must be accounted for. Appropriate forms of deliveries and returns must be 
signed by the person responsible. 


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8.3 
Selection of Study Population 
Determination of study eligibility will be made by the Investigator on the basis of the inclusion 
and exclusion criteria listed below. 
8.3.1 
Inclusion Criteria 
To be considered eligible to participate in this study, a patient must meet all of the following 
inclusion criteria: 
• Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and 
< six months of age.  
• Have a clinical indication of pain or fever. 
• Have written informed consent provided by legal parent, guardian, or authorized agent 
prior to participation in the study or performance of any study-only related procedures. 
8.3.2 
Exclusion Criteria 
To be considered eligible to participate in this study, a patient must not meet any of the following 
exclusion criteria: 
• Have inadequate intravenous access. 
• Have an uncorrected ductus dependent congenital heart disease. 
• Have any history of allergy or hypersensitivity to NSAIDs or aspirin. 
• Have a current history of uncorrected hypovolemia or acute renal disease.   
• Have a current history of acute liver disease.    
• Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to 
dosing. Have received another investigational drug within the past 30 days. 
• Be otherwise unsuitable for the study, in the opinion of the Investigator.  
8.4 
Prior and Concomitant Therapy 
Concomitant medication will be collected during the Screening/Baseline Period through Study 
Hour 48 or discharge, whichever occurs first. Intravenous concomitant medications may be 
administered through the same line if it is adequately flushed before and after administration of 
the IMP.  


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Ibuprofen is metabolized by the cytochrome P450 CYP2C9 and CYP2C8 enzymes. CYP2C9 
activity is low immediately after birth, increasing to peak at a young age. Co-administration of 
medications that are primarily metabolized by, or are inducers or inhibitors of CYP2C9 are listed 
in Table 8-2 and should be closely monitored or avoided. The Investigator’s Brochure should 
also be used as a reference for the co-administration of medications.  
Table 8-2 
Selected Inducers and Inhibitors of CYP2C9 
Substrate 
Inhibitors 
Inducers 
Ibuprofen 
 
 
 
 
 
 
• 
Amiodarone 
• 
Efavirenz 
• 
Fluconazole 
• 
Fluvastatin 
• 
Ketoconazole 
• 
Sulfamethoxazole 
• 
Zafirlukast 
• Carbamazepine 
• Phenobarbital 
• Phenytoin 
• Rifampin 
 
 
 
 
8.4.1 
Excluded Medications/Procedures/Therapy 
The following medications will be restricted for the specified times prior to receiving the first 
dose of IMP through study hour 48: 
• Any NSAID (excluding IMP) will be restricted 4 hours prior to receiving the first dose of 
IMP through study hour 48.  
• Acetaminophen will be restricted 4 hours prior to receiving the first dose of IMP through 
study hour 48. 
9 
EXPERIMENTAL PROCEDURES 
9.1 
Overview – Schedule of Time and Events 
This is a multi-center, open-label, in-patient, single and/or multiple dose study in pediatric 
subject, aged birth (> 37 weeks gestational age) to < 6 months of age, with a clinical indication 
of pain and fever. A total of twenty-four subjects, between the ages of birth (> 37 weeks 
gestational age) to less than six (6) months of age, will receive IMP.  
This 72 hour study will consist of a Screening/Baseline Period (up to 48 hours prior to the first 
dose of IMP), a Treatment Period (beginning with the first dose of IMP and continuing for 48 
hours) and a Post-Treatment Period (beginning at the end of the Treatment Period and continuing 
for 24 hours). 


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During the Screening/Baseline Period, an evaluation of the inclusion and exclusion criteria, a 
complete medical history, and a physical examination will be conducted. Participant’s vital signs 
will be measured before the start of the IMP, at regular intervals following the initial dose of 
IMP, and before and after multiple (as needed, PRN) IMP doses. A review of baseline signs and 
symptoms, including pain scores, concomitant medications, and laboratory assessments will be 
also conducted.  
During the Treatment Period, the initial dose of investigational medicinal product will be 
administered over a 10 minute period. Subsequent doses of IMP will be administered at the 
investigators discretion. Pharmacokinetic sampling will be performed utilizing a sparse sampling 
technique following the initial dose of IMP. Vital signs, pains scores, laboratory assessments will 
be monitored during the treatment period and AEs will be monitored during the treatment and 
post-treatment period. All treatment emergent adverse events will be followed until resolution or 
stabilization, regardless of the assessment of severity or relationship to the study drug. 
9.2 
Measurements and Evaluations 
9.2.1 
Screening/Baseline Period 
During the Screening/Baseline Period, the following evaluations will be performed to determine 
the subject’s eligibility for this study: 
• Informed consent (by parent or legal guardian) 
• Inclusion and exclusion criteria 
• Complete medical history: The medical history should be recorded at Screening/Baseline 
and should include history of hepatic, renal, neurological, endocrine, cardiovascular, and 
pulmonary disease, operations, serious illnesses and any other condition the investigator 
feels is significant. Medical history should include information related to the duration, i.e. 
the number of months must be recorded in the case report form. 
• Physical examination 
• Demographic date (age, race, ethnicity, weight, sex) 
• Baseline signs & symptoms: Any new signs and symptoms occurring since the screening 
medical history and physical exam, but prior to receiving the IMP should be recorded as 
part of the medical history.   
• Vital signs (temperature, heart rate, respiratory rate, and blood pressure) 


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• Laboratory assessment: Samples for chemistry, hematology, and coagulation will be 
obtained at Screening/Baseline. If the panels were obtained within 48 hours of Study 
Hour 0 and at the same hospital/institution and no current history or physical exam 
findings suggest a clinically relevant change is likely, these labs do not need to be 
repeated during the screening period. 
Clinical chemistry includes: 
Sodium 
Potassium 
Chloride 
Total carbon dioxide 
Glucose 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Albumin 
Total protein 
Aspartate aminotransferase 
Alanine aminotransferase 
Lactate dehydrogenase 
Hematology and coagulation include: 
White blood cell count and differential 
Hematocrit 
Hemoglobin 
Platelets 
Prothrombin time 
Partial thromboplastin time 
• Concomitant medications 
9.2.2 
Treatment Period (Study Hour 0 to Study Hour 48)  
Study Hour 0 = initiation of administration of the initial dose of IMP.  
The following assessments will be performed during the Treatment Period:  
• Vital Signs: Immediately pre-dose and post-dose, 30 minutes, 60 minutes, 120 minutes, 
and 240 minutes following each dose of IMP, at Study Hour 24, and at Study Hour 48 
(The vital sign assessments should be performed within 15 minutes of the specified 
nominal time to avoid any conflicts with the blood sampling time points).  
• Laboratory assessments: Samples for chemistry, hematology, and coagulation will be 
obtained at Study Hour 24 (± 6 hours). If the samples are taken for standard of care 


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procedures and are within the allowable time window for data collection, these labs do 
not need to be repeated during the Treatment Period; however, any missing laboratory 
assessments must be obtained.   
Clinical chemistry includes: 
 
Sodium 
 
Potassium 
 
Chloride 
 
Total carbon dioxide 
 
Glucose 
 
Blood urea nitrogen 
 
Creatinine 
 
Total bilirubin 
 
Albumin 
 
Total protein 
 
Aspartate aminotransferase 
 
Alanine aminotransferase 
Lactate dehydrogenase 
Hematology and coagulation include: 
White blood cell count and differential 
Hematocrit 
Hemoglobin 
Platelets 
Prothrombin time 
Partial thromboplastin time 
• Pharmacokinetic assessments: Immediately following completion of the first dose of IMP 
for all subjects, then utilizing sparse sampling techniques for 30 minutes, 1 hour, 2 hour, 
and 4 hours following completion of the initial dose of IMP only. (The PK assessments 
should be performed within 5 minutes of the specified nominal time to avoid any 
conflicts with the vital signs time points). 
• IMP administration: At Study Hour 0, then every 6-8 hours PRN at the investigator’s 
discretion.  
• Concomitant medications 
• Adverse event monitoring: Adverse events will be assessed regularly during the 
Treatment Period. Adverse event collection will begin at the start of IMP administration 
and continue through Study Hour 48 or discharge, whichever comes first. Subjects do not 
need to remain hospitalized for the 48-hour Treatment Period. All treatment emergent 
adverse events will be monitored until resolution or stabilization, regardless of the 
assessment of severity or relationship to the study drug. All AEs, observed by, 


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documented in the subject’s medical record, or reported to the research team must be 
recorded in both the subject’s research record and the case report form. 
9.2.3 
Post-treatment Period (Study Hour 48 to Study Hour 72) 
The following assessments will be performed during the Post-Treatment Period:  
• Vitals Signs: must be performed at Study Hour 72 (± 6 hours) or at the time of discharge, 
whichever occur first. 
• Laboratory assessments: Samples for chemistry, hematology, and coagulation will be 
obtained at Study Hour 72 (± 6 hours) or discharge, whichever occurs first. If the samples 
are taken for standard of care procedures and are within the allowable time window for 
data collection, these labs do not need to be repeated during the Treatment Period; 
however, any missing laboratory assessments must be obtained.   
Clinical chemistry includes: 
Sodium 
Potassium 
Chloride 
Total carbon dioxide 
Glucose 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Albumin 
Total protein 
Aspartate aminotransferase 
Alanine aminotransferase 
Lactate dehydrogenase 
Hematology and coagulation include: 
White blood cell count and differential 
Hematocrit 
Hemoglobin 
Platelets 
Prothrombin time 
Partial thromboplastin time 
• Adverse event monitoring: Adverse events will be assessed during the Post-Treatment 
Period up to Study Hour 72. If the subject is discharged before Study Hour 72, a phone 
call must be made to assess for any AEs following discharge up to Study Hour 72 and 
must be recorded in both the subject’s research record and the case report form. All 


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treatment emergent adverse events will be followed until resolution or stabilization, 
regardless of the assessment of severity or relationship to the study drug. 
If the subject is discharged from the hospital before Study Hour 72, all post-treatment period 
assessments should be performed before hospital discharge. A member of the research team will 
contact the subject’s parent or legal guardian by telephone to obtain a report of any adverse 
events occurring through Study Hour 72. All adverse events that occur before Study Hour 72 (in 
the hospital or after discharge) will be recorded in the subject’s case report form (CRF).  
10 
SUBJECT DISCONTINUATION  
10.1 
Circumstances for Subject Discontinuation 
Parents and/or legal guardians will be encouraged to allow the subject to complete the study; 
however, they may voluntarily withdraw their child from the study at any time and for any 
reason. The Investigator will describe in the CRF the reason for the subject’s parent(s) and/or 
legal guardian(s) choice to discontinue. If a subject withdraws before completion, every effort 
should be made to complete the assessments scheduled during the final scheduled assessment. 
A subject may be removed from the study for the following reasons; in each case, the decision to 
discontinue should be confirmed following consultation between the Investigator and Sponsor: 
• Adverse event: If a subject experiences an AE for which continued study participation 
presents an unacceptable consequence or risk to the subject, the subject may be 
discontinued.  
• Subject non-compliance: A subject’s past, current, or anticipated inability to comply 
with study visits, clinical trial medication or other processes required by the protocol may 
lead to the decision to discontinue the subject from the study.  
• Enrollment violation: If it is realized after the initiation of investigational treatment that 
a subject did not meet all eligibility requirements, the Sponsor and Investigator will 
discuss whether it is safe, ethical, and scientifically sound to keep the subject in the study 
or to discontinue the subject.  The IRB may be consulted as appropriate.   
• Concurrent Treatment: If a subject initiates a procedure or medication that may 
interfere with their study conduct or for which study involvement may pose a significant 
risk to the prescribed therapy, the subject may be discontinued.  This also includes the use 
of therapies restricted by the protocol in Section 8.4.1.      


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10.2 
Procedures for Subject Discontinuation 
If the subject is withdrawn from the study data collected on the subject up to the time of 
withdrawal must remain in the trial database (FDA 2008).  
If a decision is made to withdraw the subject from the study; the investigator should clarify with 
the subject’s parent or legal guardian if the subject is to be withdrawn from all components of the 
study or if the subject is withdrawn from the primary interventional component but if the 
subject’s parent or legal guardian would be willing to allow the investigator to continue other 
research activities as described below and in the informed consent:  
• Medical course or laboratory results obtained through non-invasive chart review 
• Vital signs, as outlined in the protocol 
• Adverse event monitoring, as outlined in the protocol  
• Post-Treatment follow-up        
If the subject’s parent and/or legal guardian permits continued follow-up of associated clinical 
outcome information as described in the previous bullets, the investigator must obtain the 
parent’s or legal guardian consent for this limited participation in the study (FDA 2008). 
Reasonable efforts should be made to monitor the subject for AEs and to complete follow-up 
assessments following discontinuation.  
The reason, level of continued follow-up, if appropriate, and documentation of limited 
participation consent, if appropriate, should be documented in the research record and the 
subject’s CRF.  
Subjects who are enrolled into the study but do not receive any IMP will be replaced. Subjects 
who withdraw from the study after receiving IMP but who do not complete the PK portion of the 
study within the first 4 hours will also be replaced.  
11 
Study or Site Termination 
If conditions arise during the study that indicate that the study should be halted or that the study 
center should be terminated, this action may be taken after appropriate consultation among the 
Sponsor, Investigator, Medical Monitor, and Study Monitor.   
Conditions that may warrant termination of the study include, but are not limited to, the 
following: 


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• The discovery of an unexpected, serious, or unacceptable risk to the subjects enrolled in 
the study 
• A decision on the part of the Sponsor to suspend or discontinue testing, evaluation, or 
development of the product 
• A study conducted at a single study site or a single study site in a multicenter study may 
also warrant termination under the following conditions: 
o Failure of the Investigator to enroll subjects into the study at an acceptable rate 
o Failure of the Investigator to comply with pertinent regulations of appropriate 
regulatory authorities 
o Submission of knowingly false information from the research facility to the 
Sponsor, Study Monitor, or appropriate regulatory authority 
o Insufficient adherence to protocol requirements 
Study termination and follow-up will be performed in compliance with the conditions set forth in 
the ICH sixth efficacy publication (E6) on Good Clinical Practice, Section 4.12, ICH E6 4.13, 
ICH E6 5.20, and ICH E6 5.21. 
12 
ADVERSE EVENTS 
Information about AEs, whether spontaneously reported by the subject, discovered by the 
Investigator by questioning/review of diary records or detected through physical examination, 
laboratory test or other means, will be collected and recorded on the adverse event form and 
followed until resolution or stabilization, regardless of your assessment of severity or 
relationship to the study drug. Information about serious adverse events (SAEs) should be 
reported to the Sponsor within 24 hours of obtaining knowledge of the event.  
12.1 
Definitions 
Adverse event: Adverse event means any untoward medical occurrence associated with the use 
of a drug in humans, whether or not considered drug related. 
Treatment-emergent adverse event: Any adverse event not present prior to the initiation of 
IMP or any adverse event already present that worsens in either intensity or frequency following 
exposure to IMP.  
Serious adverse event: An adverse event is considered “serious” if, in the view of either the 
investigator or Sponsor, it results in any of the following outcomes: 


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• death 
• a life-threatening adverse event 
• inpatient hospitalization or prolongation of existing hospitalization 
• a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions  
• a congenital anomaly/birth defect  
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they 
may jeopardize the patient or subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. 
Life-threatening adverse event: An adverse event is considered “life-threatening” if, in the 
view of either the investigator or Sponsor, its occurrence places the patient or subject at 
immediate risk of death. It does not include an adverse event or suspected adverse reaction that, 
had it occurred in a more severe form, might have caused death. 
Unexpected adverse event: An adverse event or suspected adverse reaction is considered 
“unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or 
severity that has been observed; or, if an investigator brochure is not required or available, is not 
consistent with the risk information described in the general investigational plan or elsewhere in 
the current application, as amended. “Unexpected,” as used in this definition, also refers to 
adverse events or suspected adverse reactions that are mentioned in the investigator brochure as 
occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, 
but are not specifically mentioned as occurring with the particular drug under investigation. 
Severity: The maximum severity of an AE should be assessed by the Investigator using the 
following definitions:  
• Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
• Moderate: minimal, local or noninvasive intervention indicated; may interfere with daily 
activities  
• Severe: severe or medically significant; events interrupt the participant’s normal daily 
activities and generally require systemic drug therapy or other treatment 


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Anticipated: Anticipated events include known consequences of the underlying disease or 
condition under investigation, events anticipated from any background regimen, events common 
in the study population, or re-emergence or worsening of a condition relative to pretreatment 
baseline. 
12.2 
Collection, Recording and Reporting of Adverse Events 
It is the responsibility of the Investigator to perform periodic and special assessments for AEs.  
The Investigator and clinical staff will note all AEs observed in or offered by the subject during 
administration of IMP. All clinical complaints volunteered by or elicited from the patient or 
observed by clinical staff during the study will be recorded in the appropriate area of the CRF for 
the study period indicated.  
If any AE occurs during or after dosing with IMP, the patient will receive appropriate treatment 
and medical supervision. In addition, the Investigator will record AE, whether or not judged to be 
IMP-related, on the appropriate page of the CRF and will provide all requested information (e.g., 
date and time of occurrence, date and time of resolution [or information to indicate that it is still 
ongoing], severity, seriousness, relationship to IMP administration, causality of the event, IMP or 
other action taken in response to the event, and outcome of the AE). Definitions of seriousness, 
severity and anticipated are provided in Section 12.1. Definitions of causality, actions taken and 
outcome are provided in the CRF. 
The investigator must report initial information on all SAEs events to the Sponsor within 24 
hours of obtaining knowledge of the event. Furthermore, the investigator must complete the SAE 
forms within 72 hours of obtaining knowledge of the SAE. 
The Investigator is responsible for informing their IRB in accordance with local requirements in 
force and the ICH guidelines for Good Clinical Practice (GCP) and the Food and Drug 
Administration (FDA) Title 21 Code of Federal Regulations, Part 312.64 & 312.66. 
Necrotizing enterocolitis and gastrointestinal hemorrhage are adverse events of special interest. 
Any events occurring during the study will be followed until resolution or stabilization, 
regardless of the assessment of severity or relationship to the study drug.   
12.3 
Follow-up of Adverse Events 
All treatment emergent adverse events will be followed until resolution or stabilization, 
regardless of severity or relationship to the study drug.  
All serious adverse events should be followed until resolved. 


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13 
STATISTICAL METHODS AND DATA ANALYSIS 
There is no statistical analysis plan for this study. Results will be analyzed and reported 
descriptively.  
13.1 
General Overview 
Formal sample size calculations were not performed. The intent is to enroll 24 subjects to 
provide descriptive safety data. Continuous data will be summarized in tables listing the mean, 
standard deviation or standard error. All data will be listed by patient. Safety will be evaluated on 
the basis of vital signs and treatment-emergent AEs. AE data will be listed individually and 
summarized by body system organ class and preferred terms within system organ class 
(MedDRA). Serious and/or unexpected AEs will also be discussed on a case-by-case basis. On 
the basis of plasma ibuprofen concentration-time data, PK parameters will be estimated by using 
a non-compartmental model. 
13.2 
Populations of Interest 
The populations of interest for analysis are defined as below: 
Safety Population: The safety analysis population consists of all participants who were enrolled 
and received at least part of the IMP; no treated participants will be excluded from the safety 
analysis population. Safety analysis will be conducted on an as treated basis.  
Pharmacokinetic-evaluable Population: Participants who received the single dose of IMP over 
the 10 minute infusion period and have the primary PK assessments in the 48 hour study period 
will be eligible for inclusion in the pharmacokinetic-evaluable population (PEP).   
13.3 
Baseline Comparability 
Descriptive statistics of demographic, background and baseline clinical variables will be 
provided for all subjects.  
13.4 
Safety Analysis 
The participant population of interest for the safety analyses is the safety analysis population.  
Safety will be evaluated on the basis of treatment emergent AEs (Section 7.2). 
AE data will be listed individually and summarized by body system organ class and preferred 
terms within system organ class (MedDRA). Serious and/or unexpected AEs will also be 
discussed on a case by case basis.  Each AE will be counted only once for a given participant. If 


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the same AE occurs on multiple occasions, the highest severity and least favorable relationship 
reported will be assumed. If two or more AEs are reported as a unit, the individual terms will be 
reported as separate experiences.   
13.5 
PK Analysis 
On the basis of plasma ibuprofen concentration time data, the following PK parameters will be 
estimated by using a non-compartmental model: 
• AUC0-t, calculated by using the linear-log trapezoidal rule: linear trapezoidal rule up to 
time to maximum concentration, and then a log trapezoidal rule for the remainder of the 
curve, where t corresponds to the last measurable time point 
• AUC0-∞ = AUC0-t + Ct/λz, where Ct is the last measurable ibuprofen concentration and λz 
is the terminal elimination rate constant calculated by using log linear regression of the 
terminal elimination phase of the plasma concentration versus time curve 
• Cmax of ibuprofen estimated by inspection of the ibuprofen concentration time curve 
• Tmax estimated by inspection of the ibuprofen concentration time curve 
• Terminal T1/2 = ln(2)/λz 
13.6 
Interim Analysis 
No interim analysis is planned 
13.7 
Sample Size Determination 
A total of 24 subjects will be enrolled in the study.  No power calculations will be performed. If 
required, subjects will be replaced as described in Section 10.2 for a total of 24 PK-evaluable 
subjects. 
14 
STUDY MANAGEMENT AND DATA COLLECTION 
14.1 
Confidentiality 
All information regarding the nature of the proposed investigation provided by the Sponsor or 
Study Monitor to the Investigator (with the exception of information required by law or 
regulations to be disclosed to the IRB, the subject, or the appropriate regulatory authority) must 
be kept in confidence by the Investigator. 
The anonymity of participating subjects must be maintained. Subjects will be identified by an 
assigned subject number on CRFs and other study documents submitted to the Study Monitor. 


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Documents that will not be submitted to the Study Monitor and that identify the subject (e.g., the 
signed informed consent document) must be maintained in strict confidence by the Investigator, 
except to the extent necessary to allow auditing by the appropriate regulatory authority, the Study 
Monitor, or Sponsor representatives. 
14.2 
Source Documents 
Source data are contained in source documents.  Examples of these original documents, and data 
records include: hospital records, clinical and office charts, laboratory notes, memoranda, 
subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate and 
complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject 
files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments 
involved in the clinical trial. The Monitor, representatives of the Sponsor and the applicable 
regulatory authority will be allowed access to source documentation. 
14.3 
Case Report Forms 
All required study information must be recorded on the appropriate CRF pages. CRFs are 
considered complete when all data fields have been completed. In addition, as the person 
ultimately responsible for the accuracy of all CRF data, the Investigator must sign the 
Investigator’s Statement in each subject’s CRF. 
The Investigator must make study data accessible to the Clinical Monitor, to other authorized 
representatives of the sponsor, and to the appropriate regulatory authority inspectors. The 
original CRF for each subject will be checked against source documents at the study site by the 
Clinical Monitor. A copy of the final CRF will be placed in the Investigator’s study file, and the 
original will be taken by the Clinical Monitor or sent by the site to the Clinical Monitor.  
14.4 
Study Files 
Documentation concerning Investigator data, IRB data, and clinical laboratory data (when 
applicable) is required before shipment of IMP to the study site.  Copies of these documents as 
well as supplemental information, such as the Investigator’s Brochure and Responsibilities and 
Obligations of Investigators and Sponsors, will be kept on-site in a special study file. This file 
also will contain drug accountability (receipt/dispensing) records, Sponsor/Investigator 
correspondence, IRB correspondence, changes to the protocol, information regarding monitoring 
activities, subject exclusion records, biological samples records, and CRFs. 


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14.5 
Records Retention 
According to 21CFR312.62, all CRFs, as well as supporting documentation and administrative 
records, must be retained by the Investigator for a minimum of two years following notification 
that the appropriate regulatory authority has approved the product for the indication under study, 
notification that the entire clinical investigation will not be used in support of a marketing 
application, or notification that the marketing application was not approved. No study documents 
will be destroyed or moved to a new location without prior written approval from the Sponsor.  If 
the Investigator relocates, retires, or withdraws from the clinical study for any reason, all records 
required to be maintained for the study should be transferred to an agreed upon designee, such as 
the Study Monitor, another Investigator, or the institution where the study was conducted. 
15 
STUDY MONITORING, AUDITING, AND INSPECTING 
15.1 
Study Monitoring Plan 
The progress of the study will be monitored by using the following methods:  
• Periodic on-site visits 
• Electronic and/or telephone communications between the Investigator, Clinical Monitor, 
and Medical Monitor 
• Review of the CRF, clinical, and research records 
Representatives of the sponsor may accompany the Clinical Monitor to the study site during 
scheduled visits. The completed, original CRFs will be submitted to the Clinical Monitor as 
described in Section 14.3. 
15.2 
Quality Control and Quality Assurance 
To assure data completeness clinical centers will participate in a pre-study initiation meeting. 
This meeting will include representatives of the Sponsor and the Investigator and the research 
team from the clinical center. The meeting will include a thorough review of the protocol, the 
case report form, and associated study forms and logs.     
The investigator or their designee will enter data collected from the subject’s parent or legal 
guardian, from the subject’s medical and/or research record into the subject’s CRF. The 
investigator or their designee is responsible for ensuring that all data in the CRFs and Data 
Clarifications Forms (DCF) are accurate and complete and that all entries are verifiable with 
source documents. These documents should be appropriately maintained by the site. 


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The Clinical Monitor will monitor the study in accordance with FDA guidelines by comparing 
the data in the CRFs with source documents and confirm that there are no inconsistencies 
between CRF and the subject’s source documents. For screening failures, the minimum data 
collected should include all data used to evaluate the subject up to the point where screen failure 
is determined. This should include consent data and reason(s) for screening failure will be 
collected.  
Laboratory tests will be performed at local laboratories and results will be verified by the 
Clinical Monitor. PK samples will be sent to the designated central laboratory for testing. Data 
will be transferred to Data Management at during the study. 
16 
ETHICAL CONSIDERATIONS 
This study will be conducted according to the standards of ICH, GCP Guidelines, IRB 
regulations, any applicable government regulations and procedures. This protocol and any 
amendments will be submitted to a properly constituted IRB for approval of the study conduct. 
16.1 
Informed Consent 
Written informed consent must be obtained from each subject (or the subject’s legal 
guardian/representative) before performing any Screening/Baseline Period evaluations. The 
signed informed consent document will be retained by the Investigator, and a signed copy will be 
given to the subject or subject’s legal guardian/representative. The informed consent document, 
which is prepared by the Investigator, must have been reviewed and approved by the Sponsor 
and the Investigator’s IRB before the initiation of the study. The document must contain the 
20 elements of informed consent described in 21CFR50.25 and ICH E6 4.8. 
16.2 
Protocol Compliance 
Investigators must follow the IRB-approved protocol. If the Investigator intends to deviate from 
the protocol, the IRB and Sponsor should be informed prior to the deviation.  
In cases where the Investigator decides to deviate from the protocol in order to avoid an apparent 
immediate risk to a specific subject, the Investigator may proceed with emergency and 
appropriate treatment at his discretion and the IRB and Sponsor will be notified as soon as 
possible afterward. In addition, the Investigator will document in the subject’s CRF the reasons 
for the protocol deviation and the ensuing events. 
Substantive changes in the protocol include changes that affect the safety of subjects or changes 
that alter the scope of the investigation, the scientific quality of the study, the experimental 


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design, dosages, assessment variable(s), the number of subjects treated, or the subject selection 
criteria. Such changes must be prepared as a protocol amendment by the Sponsor. A protocol 
amendment must receive IRB approval before implementation.   
In parallel with the IRB approval process, the protocol amendment will be submitted to the 
appropriate regulatory authority as an amendment to the regulatory submission under which the 
study is being conducted. If a protocol amendment requires changes in the informed consent 
document, the revised informed consent document prepared by the Investigator must be 
approved by the Sponsor, Study Monitor, and the IRB. 
17 
REFERENCES 
Schwartz JI, Chan C, Mukhopadhyay S, et al. 1999. Cyclooxygenase 2 inhibition by rofecoxib 
reverses naturally occurring fever in humans. Clin Pharmacol Ther. 65:653-60.  
Krishna S, Pukrittayakamee S, Supanaranond W, et al. 1995. Fever in uncomplicated 
Plasmodium falciparum malaria: randomized double blind comparison of ibuprofen and 
paracetamol treatment. Trans R Soc Trop Med Hyg. 89:507-09.  
Guidance for Sponsors, Clinical Investigators, and IRB’s: Data Retention When Subjects 
Withdraw from FDA-Regulated Clinical Trials. October 2008. 
Taketomo CK, Hodding JH, Kraus, DM, Lexi-Comp’s Pediatric Dosing Handbook, 10th Edition. 
18 
APPENDICES 
18.1 
Responsibilities and Obligations of Investigators and Sponsors 
18.1.1 
Sponsor 
The Sponsor will: 
Conduct a pre-investigation Site Selection Visit and/or Study Initiation Visit to: 
• Establish the acceptability of the facility and record the visit in a written report 
(i.e., memorandum or form). 
• Discuss with the Investigator the proposed clinical trial and supply CRFs, the 
Investigator’s Brochure, and the protocol for his review and approval. 
• Discuss with the Investigator the regulatory requirements with respect to informed 
consent, IRB/IEC approval of the trial, the protocol, protocol amendments, and changes 
to the informed consent document. 


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• Discuss with the Investigator the timing of interim and final reports to the Study Monitor 
and the obligation to supply the Study Monitor with copies of all study-related documents 
(including IRB/IEC approval, IRB/IEC charter or equivalent, membership and 
qualifications, protocol amendments, informed consent documents, and consent changes), 
CRFs, CRF changes, and all pertinent correspondence to and from the IRB/IEC. 
Conduct periodic on-site visit(s) to: 
• Ensure adherence to the protocol. 
• Review CRFs and source documentation for accuracy and completeness of information. 
• Examine pharmacy or other IMP storage and dispensing records for documentation of 
quantity and date of receipt of IMP, dispensation and accountability data for product 
administration to each subject, loss of materials, contamination, and unused supplies. 
• Record and report (summarize) observations on the progress of the trial and continued 
acceptability of the facilities, and prepare an on-site visit report. 
• Review Investigator files for required documents, (e.g., protocols; protocol amendments; 
Investigator’s Brochure; Study Procedures Manual; IRB/IEC approval of protocols, 
amendments, and informed consent documents; IRB/IEC charter and membership; and 
communications to and from the IRB/IEC and the Study Monitor. 
18.1.2 
Investigator 
Institutional Review Board/Independent Ethics Committee 
The Investigator must assure the Study Monitor in writing that the Institutional Review 
Board/Independent Ethics Committee (IRB/IEC): 
• Meets FDA regulations as defined in 21CFR56: Institutional Review Board/Independent 
Ethics Committee. 
• Has the authority delegated by the parent Institution and found in the IRB/IEC by-laws, 
operation guidelines, or charter to approve or disapprove clinical trials and protocols, 
including informed consent and other documents (e.g., protocol amendments and 
information to be supplied to subjects concerning informed consent). 
• Complies with proper personnel make-up of the Board. 
• Convenes meetings using acceptable rules of order for making decisions, recording such 
decisions, and implementing them. 


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• Maintains files that contain (a) documentation of its decisions, such as are found in 
IRB/IEC minutes and correspondence, (b) written guidelines or by-laws governing 
IRB/IEC functions, (c) protocol, (d) protocol amendments, (e) approved informed 
consent document and information to be supplied to the subject, and (f) correspondence 
between the IRB/IEC and Investigator (e.g., consent changes, protocol amendments). 
Informed Consent of Human Subjects 
The Investigator must assure the Study Monitor in writing that the informed consent document 
for a subject: 
• Meets FDA regulations as defined in 21CFR50: Informed Consent of Trial Subjects. 
• Has been approved by the IRB/IEC, including (when required) information to be given to 
the subject regarding the trial in which he is enrolled. 
• Includes the basic elements and any additional elements of informed consent that are 
appropriate. 
• Has been signed by both the subject and the Investigator or designee, and a copy has been 
given to the subject. 
• May be provided to the subject in the "short form" informed consent document with 
written information as an alternative. 
Storage and Dispensing of Product Supplies 
The Investigator (or his Pharmacist) must assure the Study Monitor in writing that: 
• Adequate and accurate written records show receipt and disposition of all product 
supplies, including dates, serial or lot numbers, quantities received, and each quantity 
dispensed, administered, or used, with identification of each subject. 
• Purpose and reasons are given in written records for product disposal (e.g., the amount 
contaminated, broken, or lost) and the quantity that was returned to the Sponsor. 
Case Report Forms 
The Investigator must assure the Study Monitor in writing that: 
• The completed CRF accurately reflects the source documentation for each subject. 
• The CRFs and source documentation will be accessible to the Clinical Monitor during 
on-site visits. 


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Files and Records 
The Investigator must assure the quality, integrity, and content of his/her files, which will be 
subject to audit by the Study Monitor and the appropriate regulatory authority inspectors.  The 
files must contain, as minimum: 
• Significant correspondence to/from the IRB/IEC and to/from the Clinical Monitor. 
• Documents including the following: 
o IRB/IEC-approved protocols. 
o IRB/IEC-approved protocol amendments. 
o IRB/IEC-approved informed consent/assent documents and information to be 
supplied to the subject. 
o IRB/IEC-approved recruitment advertisement(s) 
o IRB/IEC charter, membership, and qualifications of each member. 
• Clinical supplies records including the following: 
o Receipt, date and quantity, and batch or lot number. 
o Disposition dates and quantity administered to each subject. 
o Inventory records. 

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