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Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-Related Pain
This study is not yet open for participant recruitment.
Verified by Janssen Korea, Ltd., Korea, December 2008
Sponsored by: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00797017
  Purpose

Drug class: FDA classfication - Class 'C', The primary objective of this study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.


Condition Phase
Low Back Pain
Phase IV

MedlinePlus related topics: Back Pain Spinal Diseases
Drug Information available for: Fentanyl Citrate Fentanyl
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-Related Pain: Multicenter, Open Label, Prospective, Observational Study

Further study details as provided by Janssen Korea, Ltd., Korea:

Estimated Enrollment: 1279
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. Each patients will be evaluated their pain intensity every 28 days during 8 weeks. The secondary objectives are to observe the improvement of the following variable 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's preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated.

start with 12mcg/h and flexible dose depending on patient's pain relief, treatment period: 56 days

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 20 years or older
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797017

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Study ID Numbers: CR015409
Study First Received: November 20, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00797017  
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Chronic Pain
Fentanyl Matrix
Spinal disorder-related pain

Study placed in the following topic categories:
Spinal Diseases
Signs and Symptoms
Fentanyl
Musculoskeletal Diseases
Neurologic Manifestations
Low Back Pain
Pain
Bone Diseases
Back Pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009