Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Chronic low back pain (not related to cancer) for at least 3 months

• current use of short-acting opioid (narcotic pain medication) for at least 4 weeks

• initiating fentanyl transdermal patch.

Exclusion Criteria:

• Confusion or reduced level of consciousness

• skin disease

• malignancies (cancer)

• currently hospitalized

• treated with a long-acting opioid within the last 2 months

• pregnant or breast-feeding

• abusing drugs or alcohol