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A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00532038
Recruitment Status : Terminated (Corporate decision)
First Posted : September 19, 2007
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.

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 the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) Phase 3

Detailed Description:
The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Study Start Date : September 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Ketoprofen
U.S. FDA Resources


Intervention Details:
    Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
    Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.


Primary Outcome Measures :
  1. To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient completed a previous efficacy study of ThermoProfen.

Exclusion Criteria:

  • Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
  • Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
  • Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
  • Patient has a relevant history of serious gastrointestinal disease.
  • Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
  • Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
  • Patient is taking warfarin, heparin, or low molecular weight heparin.
  • Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532038


Locations
United States, California
Anaheim, California, United States, 92801
San Diego, California, United States, 92103
Westlake Village, California, United States, 91361
United States, Florida
Clearwater, Florida, United States, 33761
Pembroke Pines, Florida, United States, 33024
United States, Illinois
Springfield, Illinois, United States, 62704
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Kansas
Overland Park, Kansas, United States, 66215
United States, Maryland
Baltimore, Maryland, United States, 21239
Wheaton, Maryland, United States, 20902
United States, Missouri
Kansas City, Missouri, United States, 64114
United States, New Jersey
Mercerville, New Jersey, United States
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Oregon
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Erie, Pennsylvania, United States, 16508
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Tennessee
Nashville, Tennessee, United States, 37205
United States, Texas
Houston, Texas, United States, 77090
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Study Director: Medical Monitor ZARS Pharma

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00532038     History of Changes
Other Study ID Numbers: ZMK-304
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by ZARS Pharma Inc.:
Osteoarthritis
Pain

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action