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.
NCT ID: NCT00532038
Last Updated: 2012-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
179 participants
INTERVENTIONAL
2007-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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ZARS Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
ZARS Pharma
Locations
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Anaheim, California, United States
San Diego, California, United States
Westlake Village, California, United States
Clearwater, Florida, United States
Pembroke Pines, Florida, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Overland Park, Kansas, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Kansas City, Missouri, United States
Mercerville, New Jersey, United States
Raleigh, North Carolina, United States
Lake Oswego, Oregon, United States
Duncansville, Pennsylvania, United States
Erie, Pennsylvania, United States
Anderson, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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ZMK-304
Identifier Type: -
Identifier Source: org_study_id
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