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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00797017
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : April 28, 2014
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief 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.

Condition or disease Intervention/treatment
Low Back Pain Drug: fentanyl

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

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Study Type : Observational
Actual Enrollment : 1576 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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)

Primary Outcome Measures :
  1. Pain intensity with Numeric Rating Scale [ Time Frame: baseline, week 4 and week 8 ]

Secondary Outcome Measures :
  1. Impact of activity of daily living and social activities [ Time Frame: baseline, week 4 and week 8 ]
  2. Investigator and patient global assessment [ Time Frame: baseline, week 4 and week 8 ]
  3. CGI-I (Clinical Global Impression) [ Time Frame: baseline, week 4 and week 8 ]
  4. K-ODI (Korean version of Oswestry Disability Index) [ Time Frame: baseline, week 4 and week 8 ]
  5. Improvement of sleep disturbance [ Time Frame: baseline, week 4 and week 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00797017

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

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Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT00797017     History of Changes
Other Study ID Numbers: CR015409
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014
Keywords provided by Janssen Korea, Ltd., Korea:
Chronic Pain
Fentanyl Matrix
Spinal disorder-related pain
Additional relevant MeSH terms:
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Spinal Diseases
Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General