Back to resultsFentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
Primary Purpose
Pain
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 Chronic Pain, Pain
Eligibility Criteria
Inclusion Criteria: Patient is at least 18 and no older than 75 years of age Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks. Exclusion Criteria: Patient has active cancer Patient has a history of substance abuse or has a substance abuse disorder
Sites / Locations
- Arizona Reserach Center
- Loma Linda Center for Pain Management
- Drug Studies America
- Pain Management Institute
- Pain Management Associates
- The Center for Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Matrix Transdermal Fentanyl Patch
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse eventsTo
Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain
Secondary Outcome Measures
Pain Intensity
Patient will rate pain intensity using a 100 mm VAS in which "0" equals "No Pain" and "100" equals "The Worst Pain You Can Imagine." Patients will be instructed on how to use the VAS and will base their response on the average pain that they experienced over the previous 24 hours. VAS will be collected at all study visits except screening.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00126763
Brief Title
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant 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 Non-Malignant Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
PK results suggested product did not meet requirement for further development.
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (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 non-malignant chronic 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 non-malignant chronic 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
Keywords
Chronic Pain, 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
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Matrix Transdermal Fentanyl Patch
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fentanyl Transdermal Matrix Patch ZR-02-01
Other Intervention Name(s)
ZR-02-01
Intervention Description
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days
Primary Outcome Measure Information:
Title
Number of participants with adverse eventsTo
Description
Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Patient will rate pain intensity using a 100 mm VAS in which "0" equals "No Pain" and "100" equals "The Worst Pain You Can Imagine." Patients will be instructed on how to use the VAS and will base their response on the average pain that they experienced over the previous 24 hours. VAS will be collected at all study visits except screening.
Time Frame
12 months
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
Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.
Exclusion Criteria:
Patient has active cancer
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
Arizona Reserach Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Loma Linda Center for Pain Management
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pain Management Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pain Management Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64137
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
Learn more about this trial
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
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