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

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	Phase
Low Back Pain	Drug: fentanyl	Phase 4


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:

MedlinePlus related topics: Back Pain Chronic Pain Spine Injuries and Disorders

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	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 24, 2014
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:


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

ClinicalTrials.gov processed this record on February 26, 2015