Study Stopped
Difficulty identifying and enrolling eligible patients
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
A Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy of CHADD™ Applied Over a Transdermal Fentanyl Patch for the Treatment of Breakthrough Pain in Patients With Moderate to Severe Non-malignant Chronic Pain
1 other identifier
interventional
109
1 country
15
Brief Summary
A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Jan 2006
Shorter than P25 for phase_2 pain
15 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
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 16, 2006
CompletedFirst Posted
Study publicly available on registry
January 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJune 5, 2012
June 1, 2012
7 months
January 16, 2006
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
0, 15, 20, 60 minutes
Secondary Outcomes (4)
Adhesion assessment
3 days
Pain Relief
15, 30, 60 minutes
Patient's Global Satisfaction Assessment
60 minutes
Number of participants with adverse events
15 days
Study Arms (2)
50 mcg/hr matrix fentanyl patch
EXPERIMENTALactive 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)
Placebo Patch
PLACEBO COMPARATORplacebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch
Interventions
Patch applied every 3 days for 15 days
Placebo patch applied every 3 days for 15 days
Eligibility Criteria
You may qualify if:
- Patient is 18 through 70 years of age.
- 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.
You may not qualify if:
- Patient has active cancer.
- Patient has a history of substance abuse or has a substance abuse disorder.
- Patient is pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (15)
Arizona Reserach Center
Phoenix, Arizona, 85023, United States
Florida's Institute of Clinical Research
Jacksonville, Florida, 32207, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Medical Advanced Pain Specialists
Minneapolis, Minnesota, 55433, United States
Pain Management Associates
Independence, Missouri, 64055, United States
Analgesic Development Ltd.
New York, New York, 10022, United States
Southeast Research Institute
Charlotte, North Carolina, 28203, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Pain Consultants of Oregon, PC
Eugene, Oregon, 97401, United States
Allegheny Pain Management
Altoona, Pennsylvania, 16602, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Advanced Pain Management
Virginia Beach, Virginia, 23454, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn R Webster, MD
Lifetree Clinical 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2006
First Posted
January 18, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
June 5, 2012
Record last verified: 2012-06