Conditions: Grade I/II Ankle Sprain
Keywords: Ankle sprain soft tissue injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: drug arm 2: drug arm 3: placebo

Interventions: intervention 1: diclofenac diethylamine gel 2.32% intervention 2: diclofenac diethylamine gel 2.32% intervention 3: Placebo
Intervention descriptions: intervention 1: diclofenac diethylamine gel 2.32% twice a day intervention 2: diclofenac diethylamine gel 2.32% three times a day intervention 3: Placebo

Protocol document: