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A 4-week, Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Assess the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel for the Relief of Signs and Symptoms in Patients With Knee Osteoarthritis
This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 304 |
| Start date | 2013-10 |
| Completion | 2014-05 |
Conditions
- Osteoarthritis, Knee
Interventions
- diclofenac diethylamine, DDEA 2.32% gel
- Placebo
Primary outcomes
- Measure: Pain On Movement (POM) — 2 weeks
POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.
Countries
Germany