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

This study has been completed.

First Received on April 18, 2005. Last Updated on September 21, 2005 History of Changes

Sponsor:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00108810

Purpose

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.

Condition	Intervention	Phase
Pain Osteoarthritis, Knee	Drug: Matrix Transdermal Ketoprofen/CHADD (Controlled Heat Assisted Drug Delivery) System	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ketoprofen

U.S. FDA Resources

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

The primary objective is to assess the analgesic efficacy of transdermal ketoprofen when applied with controlled heat versus placebo in patients with mild to moderate osteoarthritis pain of the knee

Secondary Outcome Measures:

The secondary objective is to characterize the safety of transdermal ketoprofen when administered with controlled heat

Estimated Enrollment:	120
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108810

Locations

United States, California
SouthBay Pharma Research
Buena Park, California, United States, 90620
United States, District of Columbia
The Center for Rheumatology and Bone Research
Washington, District of Columbia, United States, 20006
United States, Florida
Radiant Research
Daytona Beach, Florida, United States, 32114
University Clinical Research
Pembroke Pines, Florida, United States, 33024
United States, New York
Hospital for Special Surgery
New York City, New York, United States, 10021

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00108810 History of Changes
Other Study ID Numbers:	ZMK-202
Study First Received:	April 18, 2005
Last Updated:	September 21, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:

Pain
Osteoarthritis
OA
Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012