Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain

• Status: Terminated
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.

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

Details

• Lead Sponsor: Janssen Cilag S.A.S.
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Less than a month of opioid treatment over the past 3 months

• Proven cancer and chronic stable, cancer-related pain

• Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit

• A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator

Exclusion Criteria:

• Liver or kidney problems

• Previous heart, lung or nervous disorders

• Allergy to fentanyl

• Skin condition that might interfere with absorption of the fentanyl through the skin

• Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study

• History of substance abuse