Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

Detailed Description
-----------------
The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments. The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

Official Title
-----------------
A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
* Drug: Placebo Matrix/CHADD Patch
* Drug: Ketoprofen matrix/placebo CHADD Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 through 75 years of age Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year. Exclusion Criteria: Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin). Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs. Patient has a relevant history of serious gastrointestinal disease. Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control. Patient is taking warfarin, heparin, or low molecular weight heparin. Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint). Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermoprofen<br>ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch) | Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)<br>* Transdermal patch applied to the knee for 12 hours daily.<br>* Other names: Matrix Transdermal Ketoprofen CHADD System;|
| Placebo Comparator: Placebo Matrix<br>Placebo matrix with CHADD patch. | Drug: Placebo Matrix/CHADD Patch<br>* Transdermal patch applied to the knee for 12 hours daily.<br>* Other names: Placebo patch with heating system;|
| Placebo Comparator: Ketoprofen matrix/placebo CHADD<br>Ketoprofen matrix with placebo CHADD patch (no heat) | Drug: Ketoprofen matrix/placebo CHADD Patch<br>* Transdermal knee applied to the knee for 12 hours daily.<br>* Other names: ketoprofen matrix with no heat;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Pain