At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Diclofenac Capsules low dose +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Diclofenac Capsules low dose and Diclofenac Capsules high dose for Pain, Postoperative. Completed, enrolled 30 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartMay 2015
Primary CompletionApr 2016
Study CompletionApr 2016
TodayJul 2026
First PostedApr 23, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2016
Study CompletionApr 19, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.2 years ago
Interventions
Diclofenac Capsules low dosedrug
Diclofenac Capsules high dosedrug