This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
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
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
OA pain intensity in target hand and use of rescue medication recorded in diary
Global evaluation of treatment at final visit
Treatment responder rate according to OARSI criteria
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