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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00108810
First received: April 18, 2005
Last updated: May 30, 2012
Last verified: May 2012
  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: Transdermal Ketoprofen Patch with CHADD
Drug: Placebo transdermal patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 OA Pain of the Knee

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Change from baseline in the WOMAC pain subscale score [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants wih adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Patient Global Satisfaction score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Patient global satisfaction score at Study Visit 5

  • Mean change from baseline for average pain over the last 24 hours VAS scores [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: April 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal Ketoprofen Patch with CHADD Drug: Transdermal Ketoprofen Patch with CHADD
12 hours patch application for 28 days
Other Name: Matrix Transdermal Ketoprofen/CHADD Sytem
Placebo Comparator: Placebo patch and a dummy heating unit Drug: Placebo transdermal patch
12 hours application for 28 days
Other Name: Placebo patch with dummy heating unit

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
Investigators
Principal Investigator: David Borenstein, MD The Center for Rheumatology
Principal Investigator: H F Farmer, MD Radiant Research Inc.
Principal Investigator: Larry Gilderman, DO University Clinical Research
Principal Investigator: Soledad Lee, MD Southbay Pharma Research
Principal Investigator: Joseph A Markenson, MD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00108810     History of Changes
Other Study ID Numbers: ZMK-202
Study First Received: April 18, 2005
Last Updated: May 30, 2012
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 October 19, 2014