Status:
TERMINATED
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 pa...
Detailed Description
ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Tr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient has active cancer.
- Patient has a history of substance abuse or has a substance abuse disorder.
- Patient is pregnant or breastfeeding.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00278824
Start Date
January 1 2006
End Date
August 1 2006
Last Update
June 5 2012
Active Locations (15)
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1
Arizona Reserach Center
Phoenix, Arizona, United States, 85023
2
Florida's Institute of Clinical Research
Jacksonville, Florida, United States, 32207
3
Drug Studies America
Marietta, Georgia, United States, 30060
4
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, United States, 60610