Conditions: Ankle Sprain
Keywords: Pain due to ankle sprain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 658
Healthy volunteers: yes

Brief summary:
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain

Detailed description:
To evaluate the therapeutic equivalence and safety of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) in the treatment of acute pain due to minor ankle sprain.

To demonstrate the superiority of the efficacy of the test and reference products over that of the vehicle control in the treatment of acute pain due to minor ankle sprain.

To access application site reactions and patch adhesion between treatment groups.

Arms:
arm 1: Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer) arm 2: Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.) arm 3: Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine

Interventions: intervention 1: Diclofenac epolamine intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain intervention 2: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain

Protocol document: