Status:
TERMINATED
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Cancer
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 cancer 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 cancer pain currently taking an around-the-clock opioi...
Eligibility Criteria
Inclusion
- Patient is at least 18 and no older than 75 years of age at the time of screening
- Patient has a diagnosis of cancer
- Patient has moderate to severe pain that is related to cancer or its treatment and is expected to last indefinitely and is currently taking an around-the-clock opioid to treat his/her pain
- Patient is already receiving opioid therapy, has demonstrated opioid tolerance
- A responsible adult caregiver is available in the event of an emergency at home
Exclusion
- Patient has uncontrolled or rapidly escalating pain as determined by the investigator
- Patient has a history of substance abuse or has a substance abuse disorder
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00126789
Start Date
August 1 2005
End Date
July 1 2007
Last Update
June 5 2012
Active Locations (2)
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1
Loma Linda Center for Pain Management
Loma Linda, California, United States, 92354
2
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103