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Objectives The primary objective of this study is to compare the efficacy of Ketotop (topical ketoprofen) with placebo in treating pain and function associated with OA of the signal knee i.e. knee that is being treated. The secondary objective is to evaluate the safety and tolerability of Ketotop in patients with OA of the knee. Inclusion Criteria
Men or women 50 years of age or older.
Diagnosed according to ACR criteria as having OA of the knee in addition to experiencing symptoms of at least six months duration.
Having a Functional Capacity Classification of I-III
Be experiencing pain due to OA at the signal knee, at the time of admission to the study.
Be anticipated to require continuous treatment to control arthritis symptoms for the duration of the study
Patient's undergoing physiotherapy at the time of initial evaluation, the regimen must remain unchanged throughout the study
If the patient uses a cane or other assisted devices at time of initial evaluation, then the usage must remain unchanged.
Patients taking less than or equal to 325 mg aspirin per day for non-arthritic reasons, if stable for at least 30 days prior to first dose of study medication, are eligible. Exclusion Criteria
Concomitant rheumatic or other conditions which could interfere with the accurate assessment of the signal knee, or acute joint trauma of the signal knee.
An anticipated need for any major surgical procedure or any invasive procedure that would be performed on either knee during the study .
Intra-articular injection of hyaluronate in the past 6 months.
Intra-articular injection of corticosteroids in the past 3 months to the signal joint or to any joint in the past month, or intra-muscular corticosteroid or p.o. steroid within the previous month or fluid evacuation without steroid injection, or any drug intended to modify joint structure or function.
Patients with skin wounds, open injuries or other conditions of broken skin on the signal knee.
Patients must discontinue pre-screening NSAIDS or other analgesic medications for a minimum period of 48 hours or 5 half lives of the drug, whichever is greater.
Treatment with an anticoagulant, chronic analgesic.
A varus or valgus deformity of greater than 15 degrees.
An active malignancy of any type. Patients who have had a malignancy surgically removed and who have no evidence of recurrence for at least five years are eligible. Patients who have a history of basal cell carcinoma that has been successfully treated are eligible
Peptic ulceration or gastrointestinal bleeding
Inflammatory bowel disease, chronic or acute renal or hepatic disorder, a significant coagulation defect.
Sensitivity to ketoprofen or other NSAIDS CONTACT: |
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