Status:
COMPLETED
IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
Lead Sponsor:
IDEA AG
Conditions:
Osteoarthritis; Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT00316784
Start Date
July 1 2005
End Date
May 1 2006
Last Update
March 20 2009
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