Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Brief summary
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.
Interventions
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria • Osteoarthritis 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 |
|---|---|
| Incidence of treatment-emergent adverse events | — |
| Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious treatment-emergent adverse events | — |
| Number of patients who discontinued study medication due to a treatment-emergent adverse event | — |
| WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12 | — |
Countries
United States
Outcome results
None listed