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

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00797017
First received: November 20, 2008
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Low Back Pain
Drug: fentanyl

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain intensity with Numeric Rating Scale [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of activity of daily living and social activities [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
  • Investigator and patient global assessment [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
  • CGI-I (Clinical Global Impression) [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
  • K-ODI (Korean version of Oswestry Disability Index) [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
  • Improvement of sleep disturbance [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]

Enrollment: 1576
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Drug: fentanyl
Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
002 Drug: fentanyl
(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)
003 Drug: fentanyl
Bone Fracture, starting with 12mcg/h (flexible dose)
004 Drug: fentanyl
(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)
005 Drug: fentanyl
Infection, starting with 12mcg/h (flexible dose)
006 Drug: fentanyl
(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)
007 Drug: fentanyl
Other Deformity, starting with 12mcg/h (flexible dose)

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who had unsatisfactory treatment with previous medication (severe pain: NRS = 7) and no experience with fentanyl matrix will be eligible

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797017

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

No publications provided

Responsible Party: Clinical Research Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00797017     History of Changes
Other Study ID Numbers: CR015409
Study First Received: November 20, 2008
Last Updated: April 26, 2010
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Spinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014