Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)
1 other identifier
interventional
679
1 country
36
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 ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2007
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMay 30, 2012
May 1, 2012
1 year
June 18, 2007
May 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
12 weeks
Secondary Outcomes (1)
Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale
12 weeks
Study Arms (3)
Thermoprofen
EXPERIMENTALThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery \[CHADD™\] patch)
Placebo Matrix
PLACEBO COMPARATORPlacebo matrix with CHADD patch.
Ketoprofen matrix/placebo CHADD
PLACEBO COMPARATORKetoprofen matrix with placebo CHADD patch (no heat)
Interventions
Transdermal patch applied to the knee for 12 hours daily.
Transdermal patch applied to the knee for 12 hours daily.
Transdermal knee applied to the knee for 12 hours daily.
Eligibility Criteria
You may qualify if:
- Patient is 18 through 75 years of age
- Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.
You may not qualify if:
- Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (36)
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Buena Park, California, 90620, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Hamden, Connecticut, 06518, United States
Unknown Facility
Milford, Connecticut, 06460, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Springfield, Illinois, 62704, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Overland Park, Kansas, 66215, United States
Unknown Facility
Baltimore, Maryland, 21239, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
Lansing, Michigan, 48910, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
Mercerville, New Jersey, 08619, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Lake Oswego, Oregon, 97035, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Erie, Pennsylvania, 16508, United States
Unknown Facility
Mechanicsburg, Pennsylvania, 17055, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Myrtle Beach, South Carolina, 29572, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
Unknown Facility
Houston, Texas, 77090, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
ZARS Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2008
Study Completion
September 1, 2008
Last Updated
May 30, 2012
Record last verified: 2012-05