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 |