NCT01945034

5% Topical Ibuprofen (IBU) for Ankle Sprain

Placebo-controlled, Double-blind Evaluation Of The Efficacy And Safety Of Ibuprofen 5% Topical Gel For The Treatment Of Ankle Sprain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Injuries

Interventions

Type	Name	Description
DRUG	Topical IBU twice daily	Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
DRUG	Placebo twice daily	Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
DRUG	Topical IBU three times daily	Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
DRUG	Placebo three times daily	Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-09-18
• Last updated: 2016-05-26
• Results posted: 2016-05-26

Locations

19 sites across 1 country: United States