Back to resultsFentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
Primary Purpose
Pain, Cancer
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fentanyl Transdermal Matrix Patch ZR-02-01
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain Cancer, Chronic Pain
Eligibility 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
Sites / Locations
- Loma Linda Center for Pain Management
- The Center for Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZR-02-01
Arm Description
ZR-02-01 matrix transdermal fentanyl patch
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pain intensity
Patient's evaluation of pain intensity using the VAS (100 mm)
Global Satisfaction satisfied)
Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00126789
Brief Title
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Based on PK data, product did not meet requirement for further development.
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cancer
Keywords
Pain Cancer, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZR-02-01
Arm Type
Experimental
Arm Description
ZR-02-01 matrix transdermal fentanyl patch
Intervention Type
Drug
Intervention Name(s)
Fentanyl Transdermal Matrix Patch ZR-02-01
Other Intervention Name(s)
ZR-02-01 matrix transdermal fentanyl patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Patient's evaluation of pain intensity using the VAS (100 mm)
Time Frame
12 weeks
Title
Global Satisfaction satisfied)
Description
Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Rauck, MD
Organizational Affiliation
The Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Center for Pain Management
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
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Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
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