At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 206 enrolled
Drug / intervention
Diclofenac sodium topical gel 1% +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 Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating Diclofenac sodium topical gel 1% and Placebo for Ankle Sprain. Completed, enrolled 206 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Sprain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedDec 7, 2010
Enrollment StartNov 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago
Interventions
Diclofenac sodium topical gel 1%drug
Diclofenac sodium topical gel 1%, 4 times daily
Placebodrug
Placebo, 4 times daily