Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

NCT ID: NCT00108810

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2005-10-31

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Detailed Description

Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

Conditions

Pain; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Transdermal Ketoprofen Patch with CHADD

Group Type: EXPERIMENTAL

Transdermal Ketoprofen Patch with CHADD

Intervention Type: DRUG

12 hours patch application for 28 days

Placebo patch and a dummy heating unit

Group Type: PLACEBO_COMPARATOR

Placebo transdermal patch

Intervention Type: DRUG

12 hours application for 28 days

Interventions

Transdermal Ketoprofen Patch with CHADD

12 hours patch application for 28 days

Intervention Type: DRUG

Placebo transdermal patch

12 hours application for 28 days

Intervention Type: DRUG

Other Intervention Names

Matrix Transdermal Ketoprofen/CHADD Sytem; Placebo patch with dummy heating unit

Eligibility Criteria

Inclusion Criteria

• Patient is between forty (40) and seventy-five (75) years of age.
• Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.

Exclusion Criteria

• Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
• Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Borenstein, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Rheumatology

H F Farmer, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research Inc.

Larry Gilderman, DO

Role: PRINCIPAL_INVESTIGATOR

University Clinical Research

Soledad Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Southbay Pharma Research

Joseph A Markenson, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

SouthBay Pharma Research

Buena Park, California, United States

The Center for Rheumatology and Bone Research

Washington D.C., District of Columbia, United States

Radiant Research

Daytona Beach, Florida, United States

University Clinical Research

Pembroke Pines, Florida, United States

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

ZMK-202

Identifier Type: -

Identifier Source: org_study_id