Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee
The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 (Ketoprofen in Transfersome) in Comparison to Oral Celecoxib for the Treatment of Pain Associated With Osteoarthritis of the Knee|
- Change from baseline at Week 6 on the VAS version of the WOMAC pain subscale; Change from baseline at Week 6 on the VAS version of the WOMAC function subscale; Subject global assessment of response to therapy measured on a 5-point Likert scale at Week 6
- Change from baseline at Weeks 2 and 4 for WOMAC pain and physical function scores; Subject global assessment of response to therapy at Weeks 2 and 4; Physician's global assesment of osteoarthritis at Weeks 2, 4 and 6
|Estimated Study Completion Date:||January 2004|
This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), double-dummy, parallel group, placebo- and active-controlled study to determine the safety and effectiveness of 110 mg of ketoprofen in Transfersome, applied to the skin, in subjects experiencing at least moderate pain when not taking analgesic medication secondary to osteoarthritis pain of the knee. The study hypothesis is that ketoprofen in Transfersome applied to the skin twice daily will be more effective than placebo for the relief of the signs and symptoms of osteoarthritis of the knee as measured by the Visual Analog Scale (VAS) of the Western Ontario and McMaster Universities Index (WOMAC) pain, WOMAC function and subject global asessment of response to therapy at Week 6. WOMAC is a questionaire consisting of 24 questions designed to assess the three dimensions of pain, disability and joint stiffness in osteoarthritis of the knee. Safety evaluations include reports of adverse events, laboratory tests and skin irritation.
Patients will receive one of the following treatments for six weeks - 110 mg ketoprofen in Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice per day, 100 mg celecoxib administered orally twice per day plus placebo Transfersome applied to the skin twice per day, Placebo Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice twice per day.