Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant 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
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 non-malignant chronic 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 Non-Malignant Chronic 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, non-malignant chronic pain
Secondary outcome: To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe, non-malignant chronic 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 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.
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
- 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
Locations and Contacts
Arizona Reserach Center, Phoenix, Arizona 85023, United States
Loma Linda Center for Pain Management, Loma Linda, California 92354, United States
Drug Studies America, Marietta, Georgia 30060, United States
Pain Management Institute, Overland Park, Kansas 66211, United States
Pain Management Associates, Kansas City, Missouri 64137, United States
The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States
Additional Information
Starting date: July 2005
Last updated: January 4, 2008
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