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

ZARS Pharma

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Ketoprofen matrix/placebo CHADD Patch; Drug: Placebo Matrix/CHADD Patch; Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488267

ZMK-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 679 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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679 participants in 3 patient groups, including a placebo group

Thermoprofen

Experimental group

Description:

ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery \[CHADD™\] patch)

Treatment:

Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)

Placebo Matrix

Placebo Comparator group

Description:

Placebo matrix with CHADD patch.

Treatment:

Drug: Placebo Matrix/CHADD Patch

Ketoprofen matrix/placebo CHADD

Placebo Comparator group

Description:

Ketoprofen matrix with placebo CHADD patch (no heat)

Treatment:

Drug: Ketoprofen matrix/placebo CHADD Patch