Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
Information source: ZARS Pharma Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer
Intervention: Fentanyl Transdermal Matrix Patch ZR-02-01 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ZARS Pharma Inc.
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.
Clinical Details
Official title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
Secondary outcome: To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe cancer pain being treated with the ZR-02-01 matrix transdermal fentanyl patch
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 opioid. Patients will discontinue their current opioid regimen and begin
using ZR-02-01 as soon as possible under the direction of the physician investigator upon
entry into the study. Patient's dose of ZR-02-01 will be determined by the investigator
using sponsor-provided conversion. Pain therapy will be under the supervision of the
physician investigator.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Loma Linda Center for Pain Management, Loma Linda, California 92354, United States
The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States
Cache Valley Cancer Treatment, Logan, Utah 84341, United States
Additional Information
Starting date: August 2005
Last updated: January 3, 2008
|
