Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.

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

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• spine related and extremity pain lasting for 3 months or longer

• pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours

• good overall health condition based on the medical history and clinical laboratory tests

• participants using appropriate contraception in case of childbearing potential during the study period.

Exclusion Criteria:

• history of hypersensitive reaction to narcotic analgesics

• history of narcotic abuse

• serious psychotic disorder

• unable to use transdermal analgesics due to a dermatological condition

• history of CO2 retention (e.g., chronic obstructive pulmonary disease)

• surgery in the area with pain within 7 days prior to initiation of the clinical study.