Trials / Completed
CompletedNCT01626118
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 373 (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 | capsules, 40 mg, TID |
| DRUG | Indomethacin | capsules, 40 mg, BID |
| DRUG | Indomethacin | capsules, 20 mg, TID |
| DRUG | Placebo | capsules |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2012-06-22
- Last updated
- 2014-03-17
- Results posted
- 2014-03-17
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01626118. Inclusion in this directory is not an endorsement.