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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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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)

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years and older (Adult, Senior)
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

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00797017 History of Changes
Other Study ID Numbers:	CR015409
First Posted:	November 24, 2008
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:

Back Pain; Low Back Pain; Spinal Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Fentanyl; Analgesics, Opioid	Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics