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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Knee	Drug: IDEA-033 (and rescue medication)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	704 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official 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
Study Start Date :	July 2005
Study Completion Date :	May 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary)
2. patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary)
3. 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 Outcome Measures :

1. Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
2. Mean number of rescue medication taken per day while in the study
3. Number of withdrawals and time to discontinuation of the study due to lack of efficacy
4. Time to onset (in days) of pain relief and time to onset of new flares during treatment
5. Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

IDEA AG

Investigators

Principal Investigator:	Gerold Stucki, Prof, MD	department of physical medicine and rehabilitation of universtity Munich

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00316784 History of Changes
Other Study ID Numbers:	CL-033-III-02/E
First Posted:	April 21, 2006
Last Update Posted:	March 20, 2009
Last Verified:	March 2009

Keywords provided by IDEA AG:

osteoarthritis; knee; IDEA-033

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis	Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases