Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain

Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain

The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch; Drug: Placebo Patch

Detailed Description

This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Reserach Center
    • Phoenix, Arizona, United States, 85029
      • Redpoint Research
  • California
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group
    • San Diego, California, United States, 92108
      • San Diego Arthritis Medical Clinic
    • Upland, California, United States, 91786
      • Boling Clinical Trials
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Radiant Research
    • Ocala, Florida, United States, 34474
      • Ocala Rheumatology
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Pain Trials Center - Brigham & Women's Hospital
    • Fall River, Massachusetts, United States, 02720
      • Phase III Clinical Trials
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10022
      • Analgesic Development Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.

Exclusion Criteria:

• Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZR-02-01 matrix fentanyl Patch; ZR-02-01 matrix fentanyl patch	Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch; Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.; Other Names: ZR-02-01
Placebo Comparator: Placebo Patch	Drug: Placebo Patch; Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period; Other Names: Placebo Transdermal Matrix Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC Knee and Hip Osteoarthritis Index	The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events		12 weeks
TOPS survey	To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health	12 weeks

Collaborators and Investigators

• Sponsor: ZARS Pharma Inc.
• Investigators: Principal Investigator: Frank Farmer, Jr, MD, Radiant Research

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: April 18, 2005
• First Submitted That Met QC Criteria: April 18, 2005
• First Posted (Estimate): April 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Chronic Pain; Osteoarthritis Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: ZMF-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No