Clinical trial NCT02424578: Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Official title: A Phase IIA, Open-Label, Safety and Pharmacokinetic Study of Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Body weight ≥18 kilograms.
* Mild to moderate acute pain requiring treatment with analgesic medication.
* Willing to have blood samples taken for PK sampling using an indwelling catheter.
* Must be able to swallow capsules and can tolerate oral medication.
* For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control

Exclusion Criteria:

* Severe acute pain
* Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug.
* Emergency surgery
* History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID
* History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
* Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac
* Current use of any medication that might affect the pharmacokinetics of diclofenac
* History of bleeding disorders .
* Developmental delay or behavioral problems that would make it difficult to assess pain.
* Impaired liver function
* Clinically significant renal or cardiovascular disease
* Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
* Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study.
* Previous participation in this clinical study or currently taking diclofenac.

Primary outcomes:
measure: Plasma Concentration of Diclofenac
timeFrame: 0-6 hours after first dose of diclofenac
Secondary outcomes:
measure: Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination
timeFrame: Baseline to Day 3/Early Termination
Other outcomes:
Locations:
city: Sheffield
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Durham
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References: