Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain
NCT ID: NCT00108771
Last Updated: 2012-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2004-04-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZR-02-01 matrix fentanyl Patch
ZR-02-01 matrix fentanyl patch
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.
Placebo Patch
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
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
ALL
No
Sponsors
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ZARS Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Farmer, Jr, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research
Locations
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Arizona Reserach Center
Phoenix, Arizona, United States
Redpoint Research
Phoenix, Arizona, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Boling Clinical Trials
Upland, California, United States
Radiant Research
Daytona Beach, Florida, United States
Ocala Rheumatology
Ocala, Florida, United States
Tampa Medical Group
Tampa, Florida, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Pain Trials Center - Brigham & Women's Hospital
Boston, Massachusetts, United States
Phase III Clinical Trials
Fall River, Massachusetts, United States
Beth Israel Medical Center
New York, New York, United States
Analgesic Development Ltd.
New York, New York, United States
Countries
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Other Identifiers
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ZMF-202
Identifier Type: -
Identifier Source: org_study_id
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