drugset / Trial / NCT01543685
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
Timeline
- Start
- 2012-02
- Primary completion
- 2012-06
- Completion
- 2012-07
Outcome
Met primary endpoint
registry Indomethacin 40 mg TID vs Placebo; p <0.001; Difference in Least Squares Mean 441.8 (95% CI 187.1 to 696.5); ANCOVA NCT01543685 ↗
registry Indomethacin 40 mg BID vs Placebo; p = 0.046; Difference in Least Squares Mean 260.2 (95% CI 4.1 to 516.3); ANCOVA NCT01543685 ↗
registry Indomethacin 20 mg TID vs Placebo; p = 0.017; Difference in Least Squares Mean 312.7 (95% CI 56.6 to 568.9); ANCOVA NCT01543685 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Celecoxib | Other / unclassified | 200 mg | — |
| Subject | Indomethacin | Small molecule | 20 mg | — |
| Subject | Indomethacin | Small molecule | 40 mg | — |
Indications
No indication recorded.