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

Sponsored by:	IDEA AG
Information provided by:	IDEA AG
ClinicalTrials.gov Identifier:	NCT00316784

Purpose

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	Intervention	Phase
Osteoarthritis; Knee	Drug: IDEA-033 (and rescue medication)	Phase III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by IDEA AG:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	704
Study Start Date:	July 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316784

Sponsors and Collaborators

IDEA AG

Investigators

Principal Investigator:

Gerold Stucki, Prof, MD

department of physical medicine and rehabilitation of universtity Munich

More Information

Study ID Numbers:	CL-033-III-02/E
Study First Received:	April 19, 2006
Last Updated:	August 8, 2006
ClinicalTrials.gov Identifier:	NCT00316784
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IDEA AG:

osteoarthritis; knee; IDEA-033

Study placed in the following topic categories:

Osteoarthritis, Knee
Signs and Symptoms
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009