Overview

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

Status:
Terminated

Trial end date:
2006-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

ZARS Pharma Inc.

Treatments:

Fentanyl

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