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

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

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.

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

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• : 001
• : 002
• : 003
• : 004
• : 005
• : 006
• : 007

Primary Measures

• Pain intensity with Numeric Rating Scale
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No

Secondary Measures

• Impact of activity of daily living and social activities
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No
• Investigator and patient global assessment
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No
• CGI-I (Clinical Global Impression)
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No
• K-ODI (Korean version of Oswestry Disability Index)
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No
• Improvement of sleep disturbance
  • Time Frame: baseline, week 4 and week 8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Janssen Korea, Ltd., Korea Industry

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00797017

Study ID Number: CR015409

ClinicalTrials.gov Identifier: NCT00797017

Health Authority: Korea: Food and Drug Administration