Back to resultsEfficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Placebo Matrix/CHADD Patch
Ketoprofen matrix/placebo CHADD Patch
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Pain
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 through 75 years of age
- Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Thermoprofen
Placebo Matrix
Ketoprofen matrix/placebo CHADD
Arm Description
ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch)
Placebo matrix with CHADD patch.
Ketoprofen matrix with placebo CHADD patch (no heat)
Outcomes
Primary Outcome Measures
The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488267
Brief Title
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
679 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermoprofen
Arm Type
Experimental
Arm Description
ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch)
Arm Title
Placebo Matrix
Arm Type
Placebo Comparator
Arm Description
Placebo matrix with CHADD patch.
Arm Title
Ketoprofen matrix/placebo CHADD
Arm Type
Placebo Comparator
Arm Description
Ketoprofen matrix with placebo CHADD patch (no heat)
Intervention Type
Drug
Intervention Name(s)
ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Other Intervention Name(s)
Matrix Transdermal Ketoprofen CHADD System
Intervention Description
Transdermal patch applied to the knee for 12 hours daily.
Intervention Type
Drug
Intervention Name(s)
Placebo Matrix/CHADD Patch
Other Intervention Name(s)
Placebo patch with heating system
Intervention Description
Transdermal patch applied to the knee for 12 hours daily.
Intervention Type
Drug
Intervention Name(s)
Ketoprofen matrix/placebo CHADD Patch
Other Intervention Name(s)
ketoprofen matrix with no heat
Intervention Description
Transdermal knee applied to the knee for 12 hours daily.
Primary Outcome Measure Information:
Title
The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 through 75 years of age
Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
ZARS Pharma
Official's Role
Study Director
Facility Information:
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Mercerville
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
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