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

NCT00797017 | Completed

• 1 other identifier: CR015409
• Study Type: observational
• Target: 1,576
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

Chronic Pain; Fentanyl Matrix; Spinal disorder-related pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity with Numeric Rating Scale

  baseline, week 4 and week 8

Secondary Outcomes (5)

• 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

Study Arms (7)

001

Drug: fentanyl

002

Drug: fentanyl

003

Drug: fentanyl

004

Drug: fentanyl

005

Drug: fentanyl

006

Drug: fentanyl

007

Drug: fentanyl

Interventions

fentanyl DRUG

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

005

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 28, 2014

Record last verified: 2014-04