Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain

Stopped early · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00126763

Run by

ZARS Pharma Inc.

People needed

105

Starts

2005-07-01

Expected to finish

2006-12-01

Last updated by the study team

2012-06-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient has active cancer
• Patient has a history of substance abuse or has a substance abuse disorder

Where it is running

• Arizona Reserach Center — Phoenix, Arizona, United States
• Loma Linda Center for Pain Management — Loma Linda, California, United States
• Drug Studies America — Marietta, Georgia, United States
• Pain Management Institute — Overland Park, Kansas, United States
• Pain Management Associates — Kansas City, Missouri, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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