Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488267
• Other study ID #: ZMK-301
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2007
• Last updated: May 17, 2012
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No