Trials / Completed
CompletedNCT00716547
Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,399 (actual)
- Sponsor
- IDEA AG · Industry
- Sex
- All
- Age
- 46 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Detailed description
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ketoprofen in Diractin® | 50 mg (b.i.d.) |
| DRUG | ketoprofen in Diractin® | 100 mg (b.i.d.) |
| DRUG | Placebo | b.i.d. |
| DRUG | celecoxib | 100 mg (b.i.d.) |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-03-01
- Completion
- 2009-05-01
- First posted
- 2008-07-16
- Last updated
- 2009-10-16
Locations
4 sites across 4 countries: Czechia, Germany, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT00716547. Inclusion in this directory is not an endorsement.