Osteoarthritis; Knee
Conditions
Keywords
osteoarthritis; knee; IDEA-033
Brief summary
The study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control.
Interventions
DRUGIDEA-033 (and rescue medication)
Sponsors
IDEA AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of OA in at least one knee for a minimum of 6 months * aged 18-75 years old * eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment * at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee * radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren & Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline. * American College of Rheumatology (ACR) functional class I, II or III
Exclusion criteria
* intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study * history, physical examinations or radiographs suggestive of other rhematic diseases * known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy * history of peptic ulcers * severe liver or gastro-intestinal disease within the last 6 months * injections or change in oral treatment regimen of glucosamine, chondroitin sulfate, hyaluronic acid, shark cartilage, or vitamin E within 3 months prior to screening * oral or parenteral corticosteroids within 3 months prior to screening * analgesic therapy for chronic or recurrent pain conditions for indications other than OA * immunosuppressants within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary) | — |
| patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary) | — |
| change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC function subscale (co-primary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset (in days) of pain relief and time to onset of new flares during treatment | — |
| Mean number of rescue medication taken per day while in the study | — |
| Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL | — |
| Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG) | — |
| Number of withdrawals and time to discontinuation of the study due to lack of efficacy | — |
Outcome results
None listed