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

Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: fentanyl; Drug: fentanyl; Drug: fentanyl; Drug: fentanyl; Drug: fentanyl; Drug: fentanyl; 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 Type: Observational
• Enrollment (Actual): 1576

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
002	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
003	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
004	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
005	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
006	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
007	Drug: fentanyl; Infection, starting with 12mcg/h (flexible dose); Drug: fentanyl; (CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Bone Fracture, starting with 12mcg/h (flexible dose); Drug: fentanyl; (FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose); Drug: fentanyl; Other Deformity, starting with 12mcg/h (flexible dose); Drug: fentanyl; (LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose); Drug: fentanyl; Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain intensity with Numeric Rating Scale	baseline, week 4 and week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of activity of daily living and social activities	baseline, week 4 and week 8
Investigator and patient global assessment	baseline, week 4 and week 8
CGI-I (Clinical Global Impression)	baseline, week 4 and week 8
K-ODI (Korean version of Oswestry Disability Index)	baseline, week 4 and week 8
Improvement of sleep disturbance	baseline, week 4 and week 8

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 20, 2008
• First Submitted That Met QC Criteria: November 20, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Pain; Fentanyl Matrix; Spinal disorder-related pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Back Pain; Low Back Pain; Spinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: CR015409