Osteearthritis
Conditions
Keywords
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Brief summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria * OA of the knee 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 |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Global evaluation of treatment at final visit | — |
| WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 | — |
| Treatment responder rate according to OARSI criteria | — |
| 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 | — |
Countries
United States
Outcome results
None listed