Conditions: Ankle Injuries
Keywords: topical ibuprofen ankle sprain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief summary:
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Topical IBU twice daily intervention 2: Placebo twice daily intervention 3: Topical IBU three times daily intervention 4: Placebo three times daily
Intervention descriptions: intervention 1: Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days intervention 2: Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days intervention 3: Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days intervention 4: Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Protocol document: