IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
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ClinicalTrials.gov Identifier: NCT00316784 |
Recruitment Status
:
Completed
First Posted
: April 21, 2006
Last Update Posted
: March 20, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis; Knee | Drug: IDEA-033 (and rescue medication) | Phase 3 |
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 |

- 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)
- Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
- 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
- Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316784
Principal Investigator: | Gerold Stucki, Prof, MD | department of physical medicine and rehabilitation of universtity Munich |
ClinicalTrials.gov Identifier: | NCT00316784 History of Changes |
Other Study ID Numbers: |
CL-033-III-02/E |
First Posted: | April 21, 2006 Key Record Dates |
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 |