drugset / Trial / NCT01945034
5% Topical Ibuprofen (IBU) for Ankle Sprain
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-02
- Completion
- 2015-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Ibuprofen Twice Daily vs Placebo Combined; p = 0.190; LS Mean Difference 23 (95% CI -11.49 to 57.56); ANOVA NCT01945034 ↗
registry analysis (superiority or other test); Ibuprofen Twice Daily vs Placebo Combined; p = 0.426; Least Squares (LS) Mean Difference 4.8 (95% CI -6.98 to 16.49); ANOVA NCT01945034 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 5 % | Topical |
Indications
No indication recorded.