Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
NCT ID: NCT00488267
Last Updated: 2012-05-30
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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COMPLETED
PHASE3
679 participants
INTERVENTIONAL
2007-06-30
2008-09-30
Brief Summary
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Detailed Description
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The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Thermoprofen
ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery \[CHADD™\] patch)
ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Transdermal patch applied to the knee for 12 hours daily.
Placebo Matrix
Placebo matrix with CHADD patch.
Placebo Matrix/CHADD Patch
Transdermal patch applied to the knee for 12 hours daily.
Ketoprofen matrix/placebo CHADD
Ketoprofen matrix with placebo CHADD patch (no heat)
Ketoprofen matrix/placebo CHADD Patch
Transdermal knee applied to the knee for 12 hours daily.
Interventions
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ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Transdermal patch applied to the knee for 12 hours daily.
Placebo Matrix/CHADD Patch
Transdermal patch applied to the knee for 12 hours daily.
Ketoprofen matrix/placebo CHADD Patch
Transdermal knee applied to the knee for 12 hours daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.
Exclusion Criteria
* Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.
* Patient has a relevant history of serious gastrointestinal disease.
* Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
* Patient is taking warfarin, heparin, or low molecular weight heparin.
* Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).
* Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.
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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Peoria, Arizona, United States
Anaheim, California, United States
Buena Park, California, United States
San Diego, California, United States
Westlake Village, California, United States
Hamden, Connecticut, United States
Milford, Connecticut, United States
Clearwater, Florida, United States
Jupiter, Florida, United States
Pembroke Pines, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Overland Park, Kansas, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Lansing, Michigan, United States
Kansas City, Missouri, United States
Mercerville, New Jersey, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Erie, Pennsylvania, United States
Mechanicsburg, Pennsylvania, United States
Anderson, South Carolina, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Countries
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Other Identifiers
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ZMK-301
Identifier Type: -
Identifier Source: org_study_id
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