Trials / Completed
CompletedNCT00985439
Study of Diclofenac Capsules to Treat Dental Pain
A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- Iroko Pharmaceuticals, LLC · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diclofenac Test (lower dose) | 18-mg Single dose |
| DRUG | Diclofenac Test (upper dose) | 35-mg Single dose |
| DRUG | Celecoxib 400 mg | Capsules 2 x 200 mg Single-dose |
| DRUG | Placebo | Capsules 2 Single-dose |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-09-28
- Last updated
- 2012-05-22
- Results posted
- 2012-03-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00985439. Inclusion in this directory is not an endorsement.