At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 205 enrolled
Drug / intervention
Diclofenac Sodium +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 Four Times Daily in Subjects With Acute Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating Diclofenac Sodium and Placebo for Acute Ankle Sprain. Completed, enrolled 205 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of 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--
ConditionsAcute Ankle Sprain
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionAug 2011
TodayJul 2026
First PostedJan 10, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.5 years ago
Interventions
Diclofenac Sodiumdrug
Topical gel 1%-4 times daily
Placeboother
Topical gel-4 times daily