Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III Study of the Efficacy, Tolerability and Safety of the Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee, Including a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase Followed by an Open-Label Treatment Phase|
- Pain as measured by the pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at Week 2
- Pain intensity, pain relief (diary)
- Functional disability
- Use of prn rescue medication
- Quality of sleep
- Lost days of work
- Patient's and physician's global assessments of study medication
|Study Start Date:||August 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
This randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. At screening, patients whose pain is currently controlled by an analgesic will agree, after giving Informed Consent, to discontinue that analgesic. Eligible patients will be randomized (1:1 ratio) to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days. Patients will return to the clinic on Days 7, 14, 21 and 28. At Day 28, patients may choose to open a 2 month open-label period.
Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains the WOMAC pain subscale. Patients will also complete an electronic diary in which pain intensity, pain relief, and quality of sleep ratings will be captured. In addition, rescue medication consumption data will be collected. Ibuprofen will be provided as prn rescue medication.