IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00316784
• Date of registration: 19/04/2006
• Primary sponsor: IDEA AG
• Public title: IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
• Scientific title: A Double-Blind, Placebo-Controlled Evaluation of Dose Related Safety and Efficacy of Epicutaneously Applied IDEA-033 for 3 Months Treatment of OA of the Knee Followed by a Double-Blind, Dose-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 for 12 Weeks Treatment of OA of the Knee
• Date of first enrolment: July 2005
• Target sample size: 704
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00316784
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Gerold Stucki, Prof, MD
• Affiliation: department of physical medicine and rehabilitation of universtity Munich

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis; Knee

Intervention(s)

Drug: IDEA-033 (and rescue medication)

Primary Outcome(s)

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)

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)

Secondary Outcome(s)

Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)

Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL

Mean number of rescue medication taken per day while in the study

Number of withdrawals and time to discontinuation of the study due to lack of efficacy

Time to onset (in days) of pain relief and time to onset of new flares during treatment

Secondary ID(s)

CL-033-III-02/E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors