A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.

March 14, 2012 updated by: ZARS Pharma Inc.

An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee

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 the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.

Study Overview

Status

Terminated

Conditions

Osteoarthritis

Intervention / Treatment

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

Detailed Description

The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.

Study Type

Interventional

Enrollment (Actual)

179

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Anaheim, California, United States, 92801
  - San Diego, California, United States, 92103
  - Westlake Village, California, United States, 91361
- Florida
  - Clearwater, Florida, United States, 33761
  - Pembroke Pines, Florida, United States, 33024
- Illinois
  - Springfield, Illinois, United States, 62704
- Indiana
  - Evansville, Indiana, United States, 47714
- Kansas
  - Overland Park, Kansas, United States, 66215
- Maryland
  - Baltimore, Maryland, United States, 21239
  - Wheaton, Maryland, United States, 20902
- Missouri
  - Kansas City, Missouri, United States, 64114
- New Jersey
  - Mercerville, New Jersey, United States
- North Carolina
  - Raleigh, North Carolina, United States, 27612
- Oregon
  - Lake Oswego, Oregon, United States, 97035
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
  - Erie, Pennsylvania, United States, 16508
- South Carolina
  - Anderson, South Carolina, United States, 29621
- Tennessee
  - Nashville, Tennessee, United States, 37205
- Texas
  - Houston, Texas, United States, 77090
  - San Antonio, Texas, United States, 78217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient completed a previous efficacy study of ThermoProfen.

Exclusion Criteria:

Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
Patient has a relevant history of serious gastrointestinal disease.
Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
Patient is taking warfarin, heparin, or low molecular weight heparin.
Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety of long-term administration of ThermoProfen™ Time Frame: up to 12 months	up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

Study Director: Medical Monitor, ZARS Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria