An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.

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

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Participants diagnosed with osteoarthritis and chronic low back pain

• 3 months of persistent moderate to severe pain levels

• More than 3 times a week frequency or daily moderate to severe pain

• Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale) Exclusion Criteria

• History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months

• Active skin disease preventing application of the transdermal system

• Chronic pulmonary disease (lung disorder)

• Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention

• Pregnant and breastfeeding mothers