NCT01945034.

Trial name or title	Placebo‐controlled, double‐blind evaluation of the efficacy and safety of ibuprofen 5% topical gel for the treatment of ankle sprain
Methods	R, DB, PC, parallel groups
Participants	Ankle sprain, Grade I or II, age ≥ 12 years Estimated enrolment 280
Interventions	Ibuprofen gel 5% x 2 daily Ibuprofen gel 5% x 3 daily Placebo gel Treatment for 7 days, with additional 3 days as needed
Outcomes	PI on weight bearing and rest at 7 days PGE at 10 days Rescue medication Safety
Starting date	November 2013
Contact information	Pfizer
Notes	Estimated completion February 2015 Includes participants aged ≥ 12 years