Trials / Completed
CompletedNCT01229228
Study of Naproxen Capsules to Treat Dental Pain
A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- Iroko Pharmaceuticals, LLC · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naproxen Test | 200-mg single dose |
| DRUG | Naproxen Test | 400-mg (2 x 200-mg) |
| DRUG | Naprosyn | single dose |
| DRUG | Naprosyn | single dose |
| DRUG | Placebo | single dose |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2010-10-27
- Last updated
- 2012-05-22
- Results posted
- 2012-03-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01229228. Inclusion in this directory is not an endorsement.