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
1 other identifier
interventional
202
1 country
13
Brief Summary
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Apr 2004
Typical duration for phase_2 pain
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 18, 2005
CompletedFirst Posted
Study publicly available on registry
April 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJune 5, 2012
June 1, 2012
2.4 years
April 18, 2005
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of participants with adverse events
12 weeks
TOPS survey
12 weeks
Study Arms (2)
ZR-02-01 matrix fentanyl Patch
EXPERIMENTALZR-02-01 matrix fentanyl patch
Placebo Patch
PLACEBO COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.
You may not qualify if:
- Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (13)
Arizona Reserach Center
Phoenix, Arizona, 85023, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92101, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Boling Clinical Trials
Upland, California, 91786, United States
Radiant Research
Daytona Beach, Florida, 32114, United States
Ocala Rheumatology
Ocala, Florida, 34474, United States
Tampa Medical Group
Tampa, Florida, 33614, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Pain Trials Center - Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Phase III Clinical Trials
Fall River, Massachusetts, 02720, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Analgesic Development Ltd.
New York, New York, 10022, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Farmer, Jr, MD
Radiant Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
April 1, 2004
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
June 5, 2012
Record last verified: 2012-06