Clinical trial NCT04214301
Conditions: Colonoscopy
Sponsor: Braintree Laboratories
Start date: 2019-09-24; Completion date: 2019-11-21
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

Detailed description:
The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Arms: arm 1: BLI800
Interventions: intervention 1: BLI800
Intervention descriptions: intervention 1: BLI800 Bowel Preparation

Protocol documents:
Prot_SAP_000.pdf: 
NCT04214301  
STUDY PROTOCOL 
 
An Open-Label Preference Evaluation of BLI800 
 
DOCUMENT DATE: 08/01/2019 


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Protocol Number BLI800-491 
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An Open-Label Preference Evaluation of BLI800 
 
Braintree Protocol BLI800-491 
 
Version Dated 1 August 2019  
 
 
 
SPONSOR 
 
 
Braintree Laboratories, Inc. 
60 Columbian St. West 
    
  
 
 
Braintree, MA  02185 
 
 
 
 
PH: 781-843-2202 
 
MEDICAL   
 
Jack DiPalma, MD 
MONITOR  
 
University of South Alabama  
Division of Gastroenterology 
75 University Blvd, South 
UCOM 6000 
Mobile, AL 36688 
PH: 251-660-5553 
 
 
 
 
 
 
 
 
______________________________________ 
 
_______________ 
John McGowan  
 
 
 
 
 
Date 
VP, Clinical Affairs 
Braintree Laboratories, Inc.  
 
 
______________________________________ 
 
_______________ 
Principal Investigator Signature 
 
 
 
Date 
 
 
______________________________________ 
 
 
Principal Investigator Name (printed) 
 
 
 
 
 
 
 
 


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1. 
INTRODUCTION ...................................................................................................... 4 
2. 
STUDY OBJECTIVE ................................................................................................ 4 
3. 
STUDY PLAN ............................................................................................................ 4 
3.1. 
Study Design .......................................................................................................... 4 
3.2. 
Number of Subjects ............................................................................................... 5 
3.3. 
Duration of Study .................................................................................................. 5 
3.4. 
Study Preparation ................................................................................................. 5 
3.5. 
Subject Selection .................................................................................................... 5 
3.5.1. 
Inclusion Criteria ............................................................................................ 5 
3.5.2. 
Exclusion Criteria ........................................................................................... 6 
4. 
STUDY PROCEDURES ............................................................................................ 7 
4.1. 
Visit 1 ...................................................................................................................... 7 
4.1.1. 
Informed Consent ............................................................................................ 7 
4.1.2. 
Bowel Preparation Assignment ...................................................................... 7 
4.1.3. 
Dietary Restrictions ......................................................................................... 8 
4.1.4. 
Subject Questionnaires ................................................................................... 8 
4.2. 
Bowel Preparation Administration ...................................................................... 8 
4.3. 
Visit 2 ...................................................................................................................... 8 
4.3.1. 
Drug Accountability ........................................................................................ 9 
4.4. 
Tabulated Study Procedures .............................................................................. 10 
4.5 
Physician Assessments ........................................................................................ 10 
4.5.1. 
Segmental Cleansing Assessment ................................................................. 10 
4.5.2. 
Overall Cleansing Assessment ...................................................................... 11 
4.6. 
Pregnancy ............................................................................................................. 11 
5. 
ADVERSE EVENTS ................................................................................................ 11 
5.1. 
Adverse Event Definition and Reporting .......................................................... 11 
5.2 
Expected Adverse Events .................................................................................... 13 
6. 
SERIOUS ADVERSE REACTIONS AND DISCONTINUATION OF STUDY13 
7. 
INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED CONSENT .. 14 
8. 
MANAGEMENT OF INTERCURRENT EVENTS ............................................ 14 
8.1. 
Modification of Protocol ..................................................................................... 14 
8.2. 
Subjects Discontinued from the Study .............................................................. 14 
9. 
DATA ANALYSIS ................................................................................................... 15 
9.1. 
Study Endpoints - Preference ............................................................................. 15 
9.2. 
Study Endpoints - Efficacy ................................................................................. 15 
9.3. 
Study Endpoints - Safety .................................................................................... 16 
9.4. 
Sample Size .......................................................................................................... 16 
10. DRUG INVENTORY AND DISPOSITION .......................................................... 17 
11. STUDY MONITORING .......................................................................................... 17 
12. DOCUMENTS AND NOTIFICATIONS ............................................................... 17 
12.1. Informed Consent ................................................................................................ 17 
12.2. Institutional Review Board ................................................................................. 17 
12.3. Amendments to the Protocol .............................................................................. 17 
12.4. Data Records ........................................................................................................ 17 
13. PUBLICATION AND AGREEMENT ................................................................... 18 
14. INVESTIGATORS AGREEMENT ....................................................................... 18 
15. REFERENCES ......................................................................................................... 18 
 


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CLINICAL PROTOCOL SUMMARY SHEET 
 
STUDY TITLE:  
An Open-Label Preference Evaluation of BLI800 
 
 
PROTOCOL: 
     BLI800-491 
 
VERSION DATE:     1 August 2019  
 
IND NUMBER:      74,808 
 
STUDY PHASE:       4 
 
OBJECTIVE:  
To evaluate the patient satisfaction and preference of BLI800 (SUPREP 
Bowel Prep Kit) in adult patients undergoing colonoscopy. 
 
STUDY DESIGN:  This is an uncontrolled, open-label study. 
 
SUBJECTS:  
Approximately 40 male and female adult subjects will be enrolled. 
 
STUDY  
 
 
MEDICATION:  
BLI800 (SUPREP Bowel Prep Kit) 
 
 
 
DURATION:  
Subject participation in this study may last up to 30 days. 
 
 
 
PREFERENCE 
 
ENDPOINTS: 
Preference endpoints include: 
 Ease of consuming preparation 
 Preparation completion 
 Overall preparation experience 
 Would subject request again? 
 Would subject refuse if prescribed? 
 Rating of aftertaste 
 
EFFICACY  
 
ENDPOINTS: 
Overall preparation success based on investigator cleansing score. 
Preparation success is based on an overall cleansing score from the 
endoscopist of Excellent or Good. 
 
 
SAFETY 
 
ENDPOINTS: 
Treatment-emergent adverse events 
 


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1. INTRODUCTION 
 
In sigmoidoscopy, colonoscopy, radiographic examination and other medical or diagnostic 
procedures on the colon, it is important that the colon be thoroughly purged and cleansed. In 
particular, it is essential that as much fecal matter as possible be removed from the colon to 
permit adequate visualization of the intestinal mucosa.  
 
Large volume (e.g. 4L) orally administered compositions have been developed for use as 
gastrointestinal “washes” for diagnostic purposes. Such orally administered preparations are 
usually formulated as dilute or isotonic solutions of polyethylene glycol 3350 (PEG-3350) and 
electrolyte containing salts such as sodium sulfate, sodium bicarbonate, sodium chloride and 
potassium chloride1. These orally administered compositions are useful in the rapid cleansing of 
the colon for diagnostic purposes.  However, due to the large volume of poorly tasting fluid that 
must be ingested, patient compliance is often poor. 
 
One attempt to answer this problem has been to reduce the volume of preparation and improve 
its palatability. To this end, a sulfate-based bowel preparation known as BLI800 was evaluated 
in clinical studies2 and proven to be safe and effective. BLI800 was approved by FDA in 2010 
as SUPREP ® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral 
Solution. SUPREP requires the patient to consume two separate administrations of this oral 
sulfate solution (OSS).  Each administration purges the colon of fecal material.  The colon is 
cleansed after the second administration. Each administration is followed by 946 ml 
supplemental water to prevent dehydration.  The total volume of fluid intake (including 
SUPREP) is about 3L.  SUPREP was specifically formulated to prevent fluid and electrolyte 
disturbances, unlike the phosphate preparations3.   
 
While preparation compliance with SUPREP in clinical trials is very high (> 99% preparation 
completion)3,4, limited data has been collected on patient satisfaction and preference for the 
preparation. The goal of this study is collect this patient preference and satisfaction data to 
inform future development.  
 
2. STUDY OBJECTIVE 
The objective of this study is to evaluate the patient satisfaction and preference of BLI800 
(SUPREP) in adult patients undergoing colonoscopy.  
3. STUDY PLAN 
3.1. Study Design 
This is an uncontrolled, open-label study in adult patients undergoing colonoscopy. 


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3.2. Number of Subjects 
Approximately 40 male and female subjects who are undergoing colonoscopy for routinely 
accepted indications will be enrolled in this study at up to 3 study centers.  
3.3. Duration of Study  
Subject participation in this study will last up to 30 days. A screening visit (Visit 1) should be 
performed within 30 days of the colonoscopy. Subjects meeting all eligibility criteria will be 
enrolled to receive BLI800. Subjects will return to the clinic the day of colonoscopy (Visit 2) to 
complete the study.  
 
3.4. Study Preparation 
BLI800 (SUPREP Bowel Prep Kit, Braintree Laboratories, Inc.) is FDA approved for 
cleansing of the colon as preparation for colonoscopy in adults.   SUPREP consists of 
two 6 ounce doses, each containing the following ingredients in liquid form:  
 
Component 
Grams 
Na2SO4 
17.51 
MgSO4 
1.6 
K2SO4 
3.13 
Sodium Benzoate 
0.098 
Flavoring agents 
1.35 
Artificial Sweetener 
1.2 
 
Each dose will be supplied in a 6 ounce amber plastic bottle with a Clic-Loc closure. 
Each preparation kit will have a clinical label containing a caution statement, study 
code, study sponsor and kit number. Subjects will be provided with commercial 
instructions on how to complete the preparation. 
 
 
3.5. Subject Selection 
3.5.1. Inclusion Criteria 
Subjects will be admitted to the study if they are: 
1. Male or female outpatients who are undergoing colonoscopy for a routinely 
accepted indication, including (but not limited to):  
 
 
Routine screening 
 
Polyp or neoplasm history 
 
Rectal bleeding 
 
Other gastrointestinal bleeding 
 
Abdominal pain 


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 
Unknown diarrhea or constipation etiology 
 
Anemia of unknown etiology 
 
Inflammatory bowel disease 
 
Abnormal endosonography 
 
Evaluation of barium enema results  
 
Laser therapy 
 
2. 18 to 85 years of age (inclusive)  
 
3. If female, and of child-bearing potential, is using an acceptable form of birth 
control (hormonal birth control, IUD, double-barrier method, depot contraceptive, 
abstinent, or vasectomized spouse). Subjects practicing abstinence must agree to 
use an acceptable form of birth control should they become sexually active during 
the study.  Pharmacologic methods of contraception must be stable for at least one 
month prior to Visit 1 and remain stable though completion of the study. 
 
4. Negative urine pregnancy test at screening, if applicable 
 
5. In the Investigator’s judgment, subject is mentally competent to provide informed 
consent to participate in the study 
 
3.5.2. Exclusion Criteria  
Subjects who meet any of the following criteria will be excluded from the study: 
 
1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal 
obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. 
 
2. Subjects with ongoing severe, acute inflammatory bowel disease  
 
3. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, 
colectomy, gastric bypass, gastric banding, stomach stapling). Any questions 
regarding the significance of a previous gastrointestinal surgery should be directed 
to Braintree Laboratories. 
 
4. Subjects with known severe renal insufficiency (GFR < 30 mL/min/1.73m2).  
 
5. Subjects with known severe hepatic insufficiency (Child Pugh C). 
 
6. Subjects with known cardiac insufficiency (NYHA Functional Classifications 3 or 4). 
 
7. Subjects undergoing insulin therapy for any indication.  
 
8. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 
 
9. Subjects undergoing colonoscopy for foreign body removal and/or decompression. 
 


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10. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 
 
11. Subjects of childbearing potential who refuse a pregnancy test. 
 
12. Subjects allergic to any BLI800 preparation components (sodium sulfate, potassium 
sulfate, magnesium sulfate and sucralose). 
 
13. Subjects who, in the opinion of the Investigator, should not be included in the study 
for any reason, including inability to follow study procedures. 
 
14. Subjects who have participated in an investigational surgical, drug, or device study 
within the past 30 days. 
 
15. Subjects who withdraw consent before completion of Visit 1 procedures. 
 
 
4. STUDY PROCEDURES 
Study procedures are described as follows and depicted graphically in Section 4.4, below. 
4.1. Visit 1 
At the screening visit, the following procedures will be undertaken: 
 Subject is fully informed about the study and gives written agreement to study 
participation in the form of a signed informed consent form (refer to Section 4.1.1) and 
assign a subject number 
 Assess eligibility, including collection of medical history and concomitant medications 
 A urine pregnancy test will be performed on female subjects of childbearing potential 
(see Section 4.6). Subjects meeting all entry criteria will be eligible for enrollment. 
 
4.1.1. Informed Consent 
Following the informed consent process, study subjects will sign a current IRB approved 
consent form. No study procedures may be performed prior to the subject providing informed 
consent. The subject’s original signed and personally dated Informed Consent Form (together 
with any subsequent IRB approved amended versions) must be retained by the Investigator in 
the subject’s file.  A copy of the original signed and dated Informed Consent Form must be 
given to the subject. 
4.1.2. Bowel Preparation Assignment 
Eligible subjects will be assigned a SUPREP kit in sequential order. Subjects will self-
administer the study preparation starting on the day prior to their scheduled colonoscopy 


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according to the instructions on the commercial product label. Subjects will be instructed to 
bring the used preparation components when they return for colonoscopy.  
4.1.3. Dietary Restrictions 
Subjects may have a light breakfast on the day before colonoscopy, followed by clear liquids 
until the colonoscopy is completed the following day.  
Examples of acceptable clear liquids are provided below: 
 Water 
 Strained fruit juices (without pulp) including apple, orange, white grape, etc. 
 Limeade or lemonade 
 Gatorade/ Powerade 
 Ginger ale 
 Coffee or tea (do not use any dairy or non-dairy creamer) 
 Chicken broth 
 Gelatin desserts without added fruit or topping 
Note: Purple/Red liquids, Milk and Alcoholic beverages are not permitted. 
 
Non-compliance with the dietary restrictions will be documented, but will not require separate 
reporting as a protocol violation. 
 
 
4.1.4. Subject Questionnaires 
 
Subjects will be provided with a Preparation Questionnaire and Dietary Questionnaire to 
document their preparation and dietary intake (refer to Appendix A for full questionnaires), 
and to note any episodes of vomiting that may occur during the preparation. Subjects will 
complete these questionnaires starting on the morning they are scheduled to take their first 
dose of each preparation (Preparation Day 1) until they return to the study center the following 
day (Preparation Day 2). The time of food/fluid ingestion will be recorded. Site staff must 
review the descriptions and times recorded on the questionnaire at Visit 2 to confirm that 
subjects were compliant with the dietary restrictions outlined in Section 4.1.3. 
4.2. Bowel Preparation Administration 
On the day prior to their appointment, subjects will begin following the protocol specified 
dietary restrictions (as outlined in Section 4.1.3) and completing their Preparation and Dietary 
Questionnaires (refer to Appendix A). In the evening, subjects will begin consuming their 
bowel preparation according to the instructions provided by the study center (refer to product 
label). Subjects will take the second dose of bowel preparation the following morning 
according to the product label. 
4.3. Visit 2 
Subjects will return to the study center for colonoscopy following completion of the 
preparation. Subjects will bring back their preparation questionnaires and study personnel will 
review the questionnaires for completeness so that any missed responses can be captured. 


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Subjects will complete a preference questionnaire (refer to Appendix A). Any violations of the 
dietary restrictions must be confirmed with the subject. Subjects will be queried for occurrence 
of adverse events.  
 
The colonoscopy will be performed by a physician according to the site’s standard procedures 
and evaluated on a 4-point scale, as shown in Section 4.5. Endoscopists should limit the use of 
water flush to that necessary to achieve the cleansing required to achieve adequate visualization. 
Water immersion and/or exchange technique should be avoided unless it is medically indicated. 
 
4.3.1. Drug Accountability 
Subjects will be instructed to bring the used preparation components when they return for 
colonoscopy to determine compliance. Failure of a subject to return preparation components does 
not constitute a protocol violation. The staff members will perform drug accountability by 
counting used and unused preparation components.  
 
Returned study preparation materials must be accounted for on the drug inventory log and will be 
returned to the Sponsor at the completion or termination of the study, unless instructed otherwise 
by the Sponsor. 
 


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4.4. Tabulated Study Procedures 
The following graphically depicts the flow of study procedures at each visit. 
 Procedures 
Visit 1 
Screening 
Day before 
colonoscopy 
Visit 2 
Day of 
colonoscopy 
Informed Consent 
X 
 
 
Inclusion/Exclusion Criteria Review 
X 
 
 
Medical History 
X 
 
 
Urine Pregnancy Test (if applicable) 1 
X 
 
 
Dispense Drug  
X 
 
 
Instruct Subject 
X 
 
 
Dispense Preparation Questionnaire 
X 
 
 
Subject Takes the 1st  Dose of Preparation 
 
X 
 
Subject Completes Preparation & Dietary 
Questionnaires  
 
X 
X 
Subject Takes the 2nd  Dose of Preparation  
 
 
X 
Preference Questionnaire Completed2 
 
 
X 
Drug Accountability 
 
 
X 
Colonoscopy performed with Efficacy 
Grading 
 
 
X 
Collect and assess adverse event data 
 
 
X 
1 refer to Section 4.6 
 
2to be completed at Visit 2, prior to sedation 
 
4.5 Physician Assessments 
4.5.1. Segmental Cleansing Assessment 
The colonoscopist will rate each colon segment (proximal, mid, distal) using the following scale, 
factoring in the amount of effort required during both insertion and withdrawal. 
Score 
Grade 
Description 
1 
Poor 
Large amounts of fecal residue, additional 
bowel preparation required 
2 
Fair 
Enough feces even after washing and suctioning 
to prevent clear visualization of the entire 
colonic mucosa. 
3 
Good 
Feces and fluid requiring washing and 
suctioning, but still achieves clear visualization 
of the entire colonic mucosa. 


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4 
Excellent 
No more than small bits of feces/fluid which 
can be suctioned easily; achieves clear 
visualization of the entire colonic mucosa 
 
4.5.2. Overall Cleansing Assessment 
Following completion of the procedure and after each segment has been rated, the colonoscopist 
will provide a global rating of preparation quality for the entire colon (inclusive of their 
perception of all segments) using the scale outlined in Section 4.5.1.   
 
4.6. Pregnancy 
Subjects that are female and of childbearing potential must have a urine pregnancy test done at 
screening. A positive result will rule out the participation of the subject in the study. 
 
Female study subjects must be surgically sterilized or use oral contraceptives, depot 
contraceptives, double-barrier method, intrauterine device, or testify that she is monogamous 
with a vasectomized partner, or practices abstinence and will continue to do so during the 
duration of study. Subjects practicing abstinence must agree to use an acceptable form of birth 
control should they become sexually active during the study. Women who are post-menopausal 
(as defined in this section), or have had a partial or total hysterectomy or tubal ligation are not 
considered of child bearing potential. 
 
Oral contraceptives, hormone implants, and injections should be stable for at least 1 month 
before the study, until completion of the study.  Subjects are not allowed to change their birth 
control method during the course of the study. 
 
Menopausal status is defined when menses have been absent for 12 months in a woman of 
appropriate age (usually 45 to 55 years) who has no other suspected or identified cause of 
amenorrheaas. 
 
If a subject becomes pregnant during the study, the subject must be removed from the study and 
followed until one month after the end of the pregnancy.  A pregnancy will not be recorded as an 
adverse event.  
 
5. ADVERSE EVENTS  
5.1. Adverse Event Definition and Reporting 
An Adverse Event (AE) is any untoward medical occurrence associated with the use 
of a drug in humans, whether or not considered drug related. An AE can therefore be any 
unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), 


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symptom, or disease temporally associated with the use of a medicinal (investigational) product.  
Reports of vomiting on the Preparation Questionnaire must be reported as adverse event 
(multiple episodes of vomiting should be reported as a single adverse event in the Case Report 
Form). Colonoscopy and biopsy findings are not considered adverse events unless considered by 
the investigator to be related to the preparation or colonoscopy procedure. 
Adverse event collection will commence at the time the patient provides informed consent and 
will conclude with the completion of Visit 2. 
 
Subjects will be instructed to promptly report adverse events to the Investigator. The Investigator 
will record date/time of report, date/time of onset, description of the adverse event, severity of 
adverse event, action(s) taken regarding treatment of the event, action(s) taken regarding study 
participation, duration of adverse event, and the Investigator's assessment of relationship of 
adverse event to study preparation.  
 
 
 
 
 
 
 
 
 
The Investigator should assess the severity of each adverse event using the following categories: 
Grade 
Severity 
Description  
1 
Mild 
Barely noticeable, does not influence functioning 
causing no limitations of usual activities 
2 
Moderate 
Makes participant uncomfortable, influences functioning 
causing some limitations of usual activities 
3 
Severe 
Severe discomfort, treatment needed 
Severe and undesirable, causing inability to carry out usual 
Activities 
4 
Life 
threatening 
Immediate risk of death, Life threatening or disabling 
(Must be reported as serious adverse event) 
5 
Fatal 
Causes death of the participant 
(Must be reported as serious adverse event)  
 
The Investigator should assess the relationship to study drug for each adverse event using the 
following categories: 


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Categories of 
Attribution:  
Description 
UNRELATED 
There is no evidence of any causal relationship. 
POSSIBLE 
There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of 
the trial medication). However, the influence of other factors 
may have contributed to the event (e.g., the subject’s clinical 
condition, other concomitant events). 
PROBABLE 
There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely. 
DEFINITE 
There is clear evidence to suggest a causal relationship, and 
other possible contributing factors can be ruled out. 
5.2 
Expected Adverse Events 
The most common adverse reactions occurring after administration of SUPREP Bowel Prep Kit 
were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache. 
 
6. SERIOUS ADVERSE REACTIONS AND DISCONTINUATION 
OF STUDY 
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in at least one 
of the following outcomes: 
 
- 
Results in death 
- 
Is life-threatening 
- 
Requires inpatient hospitalization or prolongation of existing hospitalization 
- 
A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
- 
Is a congenital anomaly/birth defect 
- 
Requires medical or surgical intervention to prevent permanent impairment or 
damage 
 
 SAE collection will coincide with the patient providing informed consent to participate in 
the study and will conclude with the completion of Visit 2. Pre-scheduled surgeries or 
elective surgeries (that do not represent a worsening of a pre-existing condition) will not 
be considered serious adverse events. Should a serious and/or unexpected adverse event 
occur, the Investigator will notify Braintree Laboratories immediately or no later than 24 
hours after gaining knowledge of the event.  The Investigator will make a decision regarding 
continuing study participation, and may request input from Braintree Laboratories. The 
Investigator will be responsible for recommending or providing the patient with appropriate 


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medical therapy. All patients experiencing serious adverse events will be followed until 
clinically stable.  
 
 
Braintree Laboratories must be kept apprised of all follow-up information related to serious adverse 
events. In addition, Investigators must comply with the SAE reporting requirements of the 
Institutional Review Board with oversight of the study. 
 
 
Any serious and/or unexpected adverse events that occur during the study will be reported to 
Braintree Laboratories as follows: 
 
Contact Telephone Numbers: 
During Business hours 
 
 
 
 
781-843-2202 
(M-F, 8:30 am – 5:00 pm EDT)  
 
 
After hours or weekends 
 
 
 
 
781-964-9051 
 
Braintree Laboratories and its medical monitor will review the report and determine 
whether an FDA Form 3500A will also be completed and sent to FDA. 
 
 
7. INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED 
CONSENT 
 
IRB review and approval of the study protocol and Informed Consent Form will be obtained prior to 
initiation of the study.  Amendments to the study protocol and consent form generated during the 
course of the study will also require IRB approval. 
 
8. MANAGEMENT OF INTERCURRENT EVENTS 
8.1. Modification of Protocol 
Neither an Investigator nor Braintree Laboratories will modify the protocol without first 
obtaining the concurrence of the other and the IRB. Investigators that continually violate the 
protocol or commit a serious violation may be subject to termination from the study. The study 
may be halted if at any time an Investigator or Braintree Laboratories deems the incidence or 
severity of adverse events to be unacceptable. 
 
8.2. Subjects Discontinued from the Study 
Subjects may be dropped from the study for any of the following reasons: 


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 An adverse event requiring discontinuation (including failure to tolerate study medication). 
 Female participants who become pregnant during the study period. 
 Major protocol deviation from the study design by the subject that is observed or suspected 
by the Investigator 
 Subject chooses to withdraw from the study, for whatever reason. 
 Subject is lost to follow-up. 
 The Sponsor initiates an early discontinuation of the study. 
 The subject is withdrawn at the discretion of the Investigator. 
 
Braintree should be contacted if possible prior to discontinuation of any subject. 
9. DATA ANALYSIS 
Since this is an uncontrolled study, no statistical testing will be performed. Demographic data 
will be summarized using descriptive statistics.  
9.1. Study Endpoints - Preference 
Preference Questionnaire data will be summarized and presented categorically by individual 
question.  
9.2. Study Endpoints - Efficacy 
Overall preparation success or failure is the primary efficacy endpoint for this study. The 
following definition of preparation success and failure will be used: 
 
Definition of successful preparation:  
1. Overall Cleansing Assessment by the colonoscopist (Section 4.5.2) of “Excellent” or 
“Good” and does not satisfy any of the following failure criteria.    
 
Definition of failed preparation:  
1. Overall Cleansing Assessment of “Fair” or “Poor” by the colonoscopist. 
2. Any subject who did not have a colonoscopy based on the Investigator’s 
assessment of the cleansing (insufficient fecal output, unclear fecal discharge, 
etc.) or due to preparation related adverse events. 
3. Any subject for whom cleaning was not adequate for evaluation. 
 
 
 


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Unevaluable Patients: 
Subjects who were dispensed a kit but withdrew from the study prior to taking any preparation 
are excluded from the efficacy and safety analyses. Any subject who completely or partially took 
study preparation but did not have a colonoscopy due to non-preparation related reasons (e.g. 
lack of insurance, inability to return for colonoscopy) will not be included in the efficacy 
analyses. All treated subjects will be included in the safety analysis. 
 
Segmental cleansing scores will be summarized and presented categorically.  
9.3. Study Endpoints - Safety 
Adverse Events: 
All subjects who took preparation in any amount will be included in the safety analysis. All 
adverse events will be summarized based on the principle of treatment emergence. A sign or 
symptom will be regarded as treatment-emergent if it was present prior to the first dose and 
subsequently worsened in severity, or was not present prior to the first dose but subsequently 
appeared. 
 
In order to define treatment emergence for events with missing start or stop dates the following 
additional criteria will be used: 
 
if both the onset and resolution dates for a particular event are missing, then the 
event is considered treatment-emergent; 
 
if the onset date for an event is missing and the resolution date falls after the 
initiation of the first dose, then the event is considered treatment-emergent; 
 
if the onset date for an event falls after the initiation of the first dose and the 
resolution date is missing or present, then the event is considered treatment-
emergent; and 
 
if the onset date for an event falls before the initiation of the first dose and the 
stop date is missing or present, then the event is not considered treatment-
emergent. 
 
Adverse events will be collected using MedDRA category designations for body system and 
preferred term. The number and percent of subjects who experienced each adverse event will be 
presented in a tabular form.   
 
9.4. Sample Size  
Approximately 40 subjects will be enrolled and treated in the study.  This size was chosen 
because of the pilot nature of this study. 
 


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10. 
DRUG INVENTORY AND DISPOSITION 
At the conclusion of the study, all drug materials will be accounted for.  Federal law requires 
that, at the conclusion of the study, all drug materials must be returned to the study sponsor or 
destroyed according to local regulations.  
11. 
STUDY MONITORING 
 
A Braintree Laboratories Study Monitor or qualified designee will visit each study center prior to 
the commencement of the study and periodically during the course of the study in accordance 
with federal guidelines governing the sponsorship of studies. 
12. 
DOCUMENTS AND NOTIFICATIONS 
12.1. 
Informed Consent 
Written informed consent will be obtained from the subjects by study personnel and will be kept 
on file at the study center. Documentation of the consent process should be noted in the study 
source documents. 
12.2. 
Institutional Review Board 
Peer review and approval of the protocol by an appropriate Institutional Review Board is 
required prior to commencement of enrollment.  Amendments to the approved protocol must also 
be submitted to the Institutional Review Board and approved prior to their implementation.  
 
12.3. 
Amendments to the Protocol 
If Braintree Laboratories determines that there is need for an amendment, it will be produced in 
writing by Braintree Laboratories and will be made a formal part of the protocol following its 
submission and approval from the IRB.    
12.4. 
Data Records 
Braintree Laboratories will provide data collection forms for each subject. Subject medical 
records will be reviewed to verify all other data points, including potential adverse events.  
Copies of subjects’ colonoscopy and pathology reports (if applicable) may be collected for 
Braintree Laboratories after subject identifiers have been redacted by site staff. Colonoscopies 
will be recorded (if site has recording capability) and transmitted to Braintree Laboratories. The 
Investigator should retain copies of the subject consent forms and other study documents for a 
period of two years following the date of approval of a New Drug Application or supplement for 
BLI800, or, if the application is not approved, for two years after the drug investigation program 
is discontinued. The study investigator will notify Braintree Laboratories of their intent to 
dispose of the study records and allow Braintree to take possession of such records. Study 
records will be made available at reasonable times for inspection and copying if requested by a 


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properly authorized employee of Braintree Laboratories, authorized Braintree Laboratories 
designee or the Department of Health and Human Services in accordance with federal 
regulations.  
 
13. 
PUBLICATION AND AGREEMENT 
The results of this study will be published if mutually agreed by Braintree Laboratories and the 
Investigator and at a mutually agreed upon date. Investigator agrees to submit to Braintree 
Laboratories, within sixty (60) days of the proposed submission date, any proposed publication 
or presentation for prior review.  Braintree Laboratories will, within thirty (30) days after receipt, 
advise if there is any proprietary or patentable information, which should not be disclosed at the 
present time. Investigator shall not release any such proposed publication or presentation, if so 
notified by Braintree Laboratories. 
 
 
 
14. 
INVESTIGATORS AGREEMENT   
I agree to perform the protocol according to Federal Regulations and as detailed in this document 
to the best of my ability.  I recognize that if I fail to do so my participation in this study may be 
terminated.  I also agree to the publication provisions stated in Section 13, above. My signature 
on the cover page of this protocol serves as documentation of my acceptance of the terms noted 
above. 
 
 
15. 
REFERENCES 
 
1 - Davis GR, et al. Development of a Lavage Solution Associated with Minimal Water and 
Electrolyte Absorption or Secretion. Gastroenterology. 1980;78(5 Pt 1):991-5.  
 
2 - Patel V, et al. Intestinal and Renal Effects of Low-Volume Phosphate and Sulfate Cathartic 
Solutions Designed for Cleansing the Colon: Pathophysiological Studies in Fve Normal Subjects. 
Am J Gastroenterol. 2009;104(4):953-65.  
 
3 - Di Palma JA, Rodriguez R, McGowan J, Cleveland Mv. A randomized clinical study 
evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing 
preparation for colonoscopy. Am J Gastroenterol. 2009;104(9):2275-84. 
 


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4 - Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M.A randomized clinical study 
comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte 
lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36.  
 
 
 
 


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APPENDIX A: SUBJECT QUESTIONNAIRES