Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
Information source: ZARS Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015 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: Terminated
Sponsored by: ZARS Pharma Inc. Official(s) and/or principal investigator(s): Richard Rauck, MD, Principal Investigator, Affiliation: The Center for Clinical Research
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: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with adverse events
Secondary outcome: Pain intensityGlobal Satisfaction satisfied)
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
Additional Information
Starting date: August 2005
Last updated: June 4, 2012
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