At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 385 enrolled
Drug / intervention
1% diclofenac sodium plus 3% menthol +3 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 Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel Versus Controls in Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating 1% diclofenac sodium plus 3% menthol, 1% diclofenac sodium plus 0.09% menthol, and 2 other interventions for Pain. Completed, enrolled 385 participants across 3 sites.
Detailed Summary
This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedApr 2014
Primary CompletionMar 2015
Study CompletionMar 2015
TodayJul 2026
First PostedApr 1, 2014
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2015
Study CompletionMar 22, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago
Interventions
1% diclofenac sodium plus 3% mentholdrug
To be applied four times daily for 10 days.
1% diclofenac sodium plus 0.09% mentholdrug
To be applied four times daily for 10 days.
3% mentholdrug
To be applied four times daily for 10 days.
Placebo with 0.09% menthol geldrug
To be applied four times daily for 10 days.