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A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.
Details
| Lead sponsor | Amneal Pharmaceuticals, LLC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1176 |
| Start date | 2014-04 |
| Completion | 2014-12 |
Conditions
- Osteoarthritis
Interventions
- Diclofenac Sodium Topical Gel, 1%
- Voltaren Topical Gel, 1%
- Vehicle Diclofenac Sodium Topical Gel
Primary outcomes
- Change From Baseline to 4 Weeks in WOMAC Pain Score — Baseline and Week 4
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
Countries
India