Trials / Completed
CompletedNCT03434197
Safety and Efficacy of SFPP in Knee Osteoarthritis
Randomized Controlled Study to Evaluate the Safety and Efficacy of SFPP in Knee Osteoarthritis Using Diclofenac Gel as the Comparator
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 313 (actual)
- Sponsor
- Taisho Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster (SFPP) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in patients with knee osteoarthritis (OA) and to examine the safety of SFPP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esflurbiprofen | A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm) |
| DRUG | Diclofenac diethylamine | A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g) |
Timeline
- Start date
- 2018-02-05
- Primary completion
- 2021-01-11
- Completion
- 2021-01-11
- First posted
- 2018-02-15
- Last updated
- 2021-08-20
Locations
11 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03434197. Inclusion in this directory is not an endorsement.