NCT01060137

Fentanyl Matrix in Lung Cancer Pain

Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).

Detailed description

This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

Conditions

• Lung Cancer
• Pain

Interventions

Type	Name	Description
DRUG	fentanyl matrix	Fentanyl transdermal patch 12 - 25mcg/hr

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2010-02-02
• Last updated: 2010-02-05