Study Stopped
Based on PK data, product did not meet requirement for further development.
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
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
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Aug 2005
Typical duration for phase_3 pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJune 5, 2012
June 1, 2012
1.9 years
August 2, 2005
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
12 weeks
Secondary Outcomes (2)
Pain intensity
12 weeks
Global Satisfaction satisfied)
12 weeks
Study Arms (1)
ZR-02-01
EXPERIMENTALZR-02-01 matrix transdermal fentanyl patch
Interventions
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (2)
Loma Linda Center for Pain Management
Loma Linda, California, 92354, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Rauck, MD
The Center for Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 4, 2005
Study Start
August 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
June 5, 2012
Record last verified: 2012-06