Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00171626
- Lead Sponsor
- Novartis
- Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method WOMAC pain score in target knee at Week 12 WOMAC physical function score in target knee at Week 12 Global rating of disease activity by patient at Week 12
- Secondary Outcome Measures
Name Time Method WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12 Pain on movement in target knee and use of rescue medication recorded in diary Global evaluation of treatment at final visit Treatment responder rate according to OARSI criteria
Trial Locations
- Locations (1)
Novartis Consumer Health Inc
🇺🇸Parsippany, New Jersey, United States