Trials / Completed
CompletedNCT01543685
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 462 (actual)
- Sponsor
- Iroko Pharmaceuticals, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Indomethacin | 40 mg TID capsules |
| DRUG | Indomethacin | 40 mg BID capsules |
| DRUG | Indomethacin | 20 mg TID capsules |
| DRUG | Celecoxib | 200 mg capsules |
| DRUG | Placebo | Capsules |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2012-06-01
- Completion
- 2012-07-01
- First posted
- 2012-03-05
- Last updated
- 2014-02-04
- Results posted
- 2013-12-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01543685. Inclusion in this directory is not an endorsement.