Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
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
1 other identifier
interventional
30
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2015
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2016
CompletedResults Posted
Study results publicly available
July 13, 2017
CompletedJuly 13, 2017
June 1, 2017
11 months
April 20, 2015
June 14, 2017
June 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma Concentration of Diclofenac
The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.
0-6 hours after first dose of diclofenac
Secondary Outcomes (1)
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
Baseline to Day 3/Early Termination
Study Arms (2)
Diclofenac Capsules low dose
EXPERIMENTALDiclofenac Capsules low dose three times daily for up to three days
Diclofenac Capsules high dose
EXPERIMENTALDiclofenac Capsules high dose three times daily for up to three days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Sheffield, Alabama, 35660, United States
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SVP Medical Affairs, Pharmacovigilance and Medical Information
- Organization
- Iroko Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2015
First Posted
April 23, 2015
Study Start
May 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 19, 2016
Last Updated
July 13, 2017
Results First Posted
July 13, 2017
Record last verified: 2017-06