Clinical trial NCT00488267: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Buena Park
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Lansing
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Mercerville
country: United States
state: New Jersey
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Mechanicsburg
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: ZARS Pharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: