At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 658 enrolled
Drug / intervention
Diclofenac epolamine +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.
Randomized, Double-Blind, Multiple-Center, Placebo-Controlled Study Comparing the Safety and Efficacy of Generic Diclofenac Epolamine to Flector® Patch in the Treatment of Acute Pain Due to Minor Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating Diclofenac epolamine and Placebo for Ankle Sprain. Completed, enrolled 658 participants across 31 sites.
Detailed Summary
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Sprain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
Primary CompletionDec 2014
First PostedDec 2014
TodayJul 2026
First PostedDec 24, 2014
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.5 years ago
Interventions
Diclofenac epolaminedrug
Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
Placeboother
Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain