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.

This study has been terminated.
(Corporate decision)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00532038
First received: September 18, 2007
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 179
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00532038     History of Changes
Other Study ID Numbers: ZMK-304
Study First Received: September 18, 2007
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Osteoarthritis
Pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014