Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00171652
- Lead Sponsor
- Novartis
- Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Not provided
Exclusion Criteria
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method OA pain intensity in target hand at Week 4 and 6 Total AUSCAN score in target hand at Week 4 and 6 Global rating of disease activity by patient at Week 4 and 6
- Secondary Outcome Measures
Name Time Method Global evaluation of treatment at final visit OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 Treatment responder rate according to OARSI criteria OA pain intensity in target hand and use of rescue medication recorded in diary