Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer

• Patients who can fully observe the overall clinical study requirements including K-ODI completion at the investigator's discretion

• Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic

• Patients who have never been administered fentanyl matrix over the last one month

Exclusion Criteria:

• Patients with a history of the drug or alcohol abuse in the past or now

• Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)

• Patients who are unable to use a transdermal system due to skin disease

• Patients with serious mental disorder

• Patients with history of hypersensitivity to opioid analgesics

• Patients with history of CO2 retention

• Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion