A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Fentanyl; Naltrexone

Criteria

Inclusion Criteria:

• Diagnosis of chronic pain who require continuous opioid analgesia

• Must enter the study on a stable dose of Duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed.

Exclusion Criteria:

• Skin disease that precluded the use of a transdermal system

• Clinically significant laboratory abnormalities

• Significant mental status changes that result in disorientation, memory impairment, or inability to report accurately

• Illicit drug, prescription drug, or alcohol abuse

• Cardiopulmonary disease

• Pregnant or breastfeeding.