Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
NCT01272934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205
Last updated 2013-01-24
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.
Conditions
- Acute Ankle Sprain
Interventions
- DRUG
-
Diclofenac Sodium
Topical gel 1%-4 times daily
- OTHER
-
Placebo
Topical gel-4 times daily
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2011-08-31
- Completion
- 2011-08-31
Countries
- Germany
Study Locations
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