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

May 17, 2012 updated by: ZARS Pharma Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

679

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
    • California
      • Anaheim, California, United States, 92801
      • Buena Park, California, United States, 90620
      • San Diego, California, United States, 92103
      • Westlake Village, California, United States, 91361
    • Connecticut
      • Hamden, Connecticut, United States, 06518
      • Milford, Connecticut, United States, 06460
    • Florida
      • Clearwater, Florida, United States, 33761
      • Jupiter, Florida, United States, 33458
      • Pembroke Pines, Florida, United States, 33024
      • South Miami, Florida, United States, 33143
      • Tampa, Florida, United States, 33614
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Springfield, Illinois, United States, 62704
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Overland Park, Kansas, United States, 66215
    • Maryland
      • Baltimore, Maryland, United States, 21239
      • Wheaton, Maryland, United States, 20902
    • Michigan
      • Lansing, Michigan, United States, 48910
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • New Jersey
      • Mercerville, New Jersey, United States, 08619
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
      • Raleigh, North Carolina, United States, 27612
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Erie, Pennsylvania, United States, 16508
      • Mechanicsburg, Pennsylvania, United States, 17055
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Myrtle Beach, South Carolina, United States, 29572
    • Tennessee
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Houston, Texas, United States, 77090
      • San Antonio, Texas, United States, 78217
    • Utah
      • Salt Lake City, Utah, United States, 84106
    • Washington
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Study Director: Medical Monitor, ZARS Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZMK-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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