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

IDEA AG

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis; Knee

Treatments

Drug: IDEA-033 (and rescue medication)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316784

CL-033-III-02/E

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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