CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
diclofenac potassium oral solutiondrug
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.

Search/NCT02287350
NCT02287350Phase 4Completed
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A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain

Depomed·interventional·Posted Nov 10, 2014·Updated Jul 11, 2017

In Brief

A Phase 4 clinical trial evaluating diclofenac potassium oral solution for Pain. Completed, enrolled 51 participants across 5 sites.

Detailed Summary

As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 10, 2014
Enrollment StartSep 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.6 years ago

Interventions

diclofenac potassium oral solutiondrug

Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.