NCT00797017

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

Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,576 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	fentanyl	Infection, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	Bone Fracture, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	Other Deformity, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)
DRUG	fentanyl	Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-11-24
• Last updated: 2014-04-28