Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
NCT ID: NCT00278824
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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TERMINATED
PHASE2
109 participants
INTERVENTIONAL
2006-01-31
2006-08-31
Brief Summary
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Detailed Description
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Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).
The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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50 mcg/hr matrix fentanyl patch
active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)
Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Patch applied every 3 days for 15 days
Placebo Patch
placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch
Placebo Patch
Placebo patch applied every 3 days for 15 days
Interventions
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Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Patch applied every 3 days for 15 days
Placebo Patch
Placebo patch applied every 3 days for 15 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has moderate to severe non-malignant chronic pain.
* Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks.
* Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl.
Exclusion Criteria
* Patient has a history of substance abuse or has a substance abuse disorder.
* Patient is pregnant or breastfeeding.
18 Years
70 Years
ALL
No
Sponsors
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ZARS Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lynn R Webster, MD
Role: PRINCIPAL_INVESTIGATOR
Lifetree Clinical Research
Locations
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Arizona Reserach Center
Phoenix, Arizona, United States
Florida's Institute of Clinical Research
Jacksonville, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Medical Advanced Pain Specialists
Minneapolis, Minnesota, United States
Pain Management Associates
Independence, Missouri, United States
Analgesic Development Ltd.
New York, New York, United States
Southeast Research Institute
Charlotte, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Pain Consultants of Oregon, PC
Eugene, Oregon, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Advanced Pain Management
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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ZCM-201
Identifier Type: -
Identifier Source: org_study_id
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