Study Stopped
Corporate decision
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.
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
1 other identifier
interventional
179
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2007
Shorter than P25 for phase_3
20 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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedMarch 16, 2012
March 1, 2012
1.2 years
September 18, 2007
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of long-term administration of ThermoProfen™
up to 12 months
Interventions
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
You may qualify if:
- Patient completed a previous efficacy study of ThermoProfen.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (20)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Pembroke Pines, Florida, 33024, 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
Kansas City, Missouri, 64114, United States
Unknown Facility
Mercerville, New Jersey, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Lake Oswego, Oregon, 97035, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Erie, Pennsylvania, 16508, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
Unknown Facility
Houston, Texas, 77090, United States
Unknown Facility
San Antonio, Texas, 78217, 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 19, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
March 16, 2012
Record last verified: 2012-03