At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 242 enrolled
Drug / intervention
diclofenac diethylamine gel 2.32% +2 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, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating diclofenac diethylamine gel 2.32% and Placebo for Grade I/II Ankle Sprain. Completed, enrolled 242 participants across 5 sites.
Detailed Summary
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrade I/II Ankle Sprain
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedAug 10, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.9 years ago
Interventions
diclofenac diethylamine gel 2.32%drug
diclofenac diethylamine gel 2.32% twice a day
diclofenac diethylamine gel 2.32%drug
diclofenac diethylamine gel 2.32% three times a day
Placebodrug
Placebo