Status:
TERMINATED
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of non-malignant chronic pain.
Detailed Description
This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe non-malignant chronic pain currently taking an around-...
Eligibility Criteria
Inclusion
- Patient is at least 18 and no older than 75 years of age
- Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
- Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.
Exclusion
- Patient has active cancer
- Patient has a history of substance abuse or has a substance abuse disorder
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00126763
Start Date
July 1 2005
End Date
December 1 2006
Last Update
June 5 2012
Active Locations (6)
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1
Arizona Reserach Center
Phoenix, Arizona, United States, 85023
2
Loma Linda Center for Pain Management
Loma Linda, California, United States, 92354
3
Drug Studies America
Marietta, Georgia, United States, 30060
4
Pain Management Institute
Overland Park, Kansas, United States, 66211