At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating Topical IBU twice daily, Placebo twice daily, and 2 other interventions for Ankle Injuries. Completed, enrolled 304 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days