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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch; Drug: Placebo Patch

• Registration Number: NCT00108771
• Lead Sponsor: ZARS Pharma Inc.

Brief Summary

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

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-04-18
• Study First Submitted QC: 2005-04-18
• Study First Posted: 2005-04-19
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZR-02-01 matrix fentanyl Patch	ZR-02-01 Fentanyl Transdermal Matrix Patch	ZR-02-01 matrix fentanyl patch
Placebo Patch	Placebo Patch	-

Primary Outcome Measures

Name	Time	Method
WOMAC Knee and Hip Osteoarthritis Index	12 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Arizona Reserach Center; 🇺🇸 Phoenix, Arizona, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

Sharp Rees-Stealy Medical Group; 🇺🇸 San Diego, California, United States

New Orleans Center for Clinical Research; 🇺🇸 New Orleans, Louisiana, United States

Ocala Rheumatology; 🇺🇸 Ocala, Florida, United States

Tampa Medical Group; 🇺🇸 Tampa, Florida, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

Phase III Clinical Trials; 🇺🇸 Fall River, Massachusetts, United States

Pain Trials Center - Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Analgesic Development Ltd.; 🇺🇸 New York, New York, United States

Boling Clinical Trials; 🇺🇸 Upland, California, United States

San Diego Arthritis Medical Clinic; 🇺🇸 San Diego, California, United States

Radiant Research; 🇺🇸 Daytona Beach, Florida, United States