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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00488267
First received: June 18, 2007
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Drug: Placebo Matrix/CHADD Patch
Drug: Ketoprofen matrix/placebo CHADD Patch
Phase 3

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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 679
Study Start Date: June 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermoprofen
ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch)
Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Transdermal patch applied to the knee for 12 hours daily.
Other Name: Matrix Transdermal Ketoprofen CHADD System
Placebo Comparator: Placebo Matrix
Placebo matrix with CHADD patch.
Drug: Placebo Matrix/CHADD Patch
Transdermal patch applied to the knee for 12 hours daily.
Other Name: Placebo patch with heating system
Placebo Comparator: Ketoprofen matrix/placebo CHADD
Ketoprofen matrix with placebo CHADD patch (no heat)
Drug: Ketoprofen matrix/placebo CHADD Patch
Transdermal knee applied to the knee for 12 hours daily.
Other Name: ketoprofen matrix with no heat

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488267

  Show 36 Study Locations
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Study Director: Medical Monitor ZARS Pharma
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00488267     History of Changes
Other Study ID Numbers: ZMK-301
Study First Received: June 18, 2007
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Osteoarthritis
Pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014