Osteoarthritis
Conditions
Keywords
Hand osteoarthritis, Topical NSAID, Diclofenac sodium
Brief summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria: • Osteoarthritis of the hand Key
Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis * Active gastrointestinal ulcer during the last year * Known allergy to analgesic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Treatment responder rate according to OARSI criteria | — |
| 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 | — |
Countries
United States
Outcome results
None listed