Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip

April 24, 2014 updated by: Janssen Korea, Ltd., Korea

Fentanyl Matrix for the Treatment of Pain Caused by Osteoarthritis of the Knee or Hip: Improvement of Pain and Function: Multicenter, Open-label, Prospective, Observational Study

The purpose of this study is to investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, open-label, non-interventional study. The objective of this study is to investigate the utility of fentanyl matrix after 8 week treatment of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II selective inhibitors) or weak opioids [tramadol HCl with acetaminophen, tramadol or codeine (or combination with acetaminophen/ibuprofen)] in clinical practice according to the investigator's discretion. This study will investigate the usefulness of fentanyl matrix based on improvement in pain and function after Fentanyl matrix administration in patients who complained of pain caused by osteoarthritis and indicated for Fentanyl matrix administration in clinical practice at the investigator's discretion. This study will also measure the patients' functional improvement through Korean Version of WOMAC. Observational study - No investigational drug administered

Study Type

Observational

Enrollment (Actual)

742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

The study population is the patients who visit a center during the study period with the complaint of chronic pain caused by osteoarthritis of the knee or hip, and are deemed to fail to control pain in a proper way and need fentanyl matrix administration according to the investigator's discretion

Description

Inclusion Criteria:

  • Patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
  • Patients who can fully observe the overall clinical study requirements including K-WOMAC 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 strong opioid analgesics 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 subjects 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
Knee osteoarthritis, starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
Hip osteoarthritis, starting with 12mcg/h (flexible dose)
002
fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
Knee osteoarthritis, starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
Hip osteoarthritis, starting with 12mcg/h (flexible dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale
Time Frame: Baseline and week 8
Baseline and week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of sleep disturbance
Time Frame: baseline, week 4 and week 8
baseline, week 4 and week 8
Improved pain relief as measured using the K-WOMAC scale
Time Frame: baseline, week 4 and week 8
baseline, week 4 and week 8
Impact of activity of daily activities measured by 5-point likert scale and social activities measured by 5-point likert scale
Time Frame: baseline, week 4 and week 8
baseline, week 4 and week 8
Investigator and patient global assessment measured by 5-point likert scale
Time Frame: Week 4 and week 8
Week 4 and week 8
Improved pain relief as measured using the CGI-I
Time Frame: Week 4 and week 8
Week 4 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 10, 2010

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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