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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study

NCT01816503

Pain

COMPLETED

The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

NCT01688583

Chronic Pain

COMPLETED

An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain

NCT00788372

Chronic Pain

COMPLETED PHASE3

Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics

NCT00216684

Pain, Intractable

COMPLETED PHASE3

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain

NCT00214942

Chronic Low Back Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

001

fentanyl

Intervention Type DRUG

Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)

002

fentanyl

Intervention Type DRUG

(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)

003

fentanyl

Intervention Type DRUG

Bone Fracture, starting with 12mcg/h (flexible dose)

004

fentanyl

Intervention Type DRUG

(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)

005

fentanyl

Intervention Type DRUG

Infection, starting with 12mcg/h (flexible dose)

006

fentanyl

Intervention Type DRUG

(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)

007

fentanyl

Intervention Type DRUG

Other Deformity, starting with 12mcg/h (flexible dose)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fentanyl

Infection, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

Bone Fracture, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

Other Deformity, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

fentanyl

Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No