Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain

• Status: Terminated
• Trial end date: 2007-07-01
• 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 cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZARS Pharma Inc.
• Treatments: Fentanyl

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