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

Sponsor

Janssen Korea, Ltd., Korea (Industry)

Overall Status

Completed

CT.gov ID

NCT01119885

Collaborator

(none)

742

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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)].

Condition or Disease	Intervention/Treatment	Phase
Pain Osteoarthritis, Hip Osteoarthritis, Knee	Drug: fentanyl matrix Drug: fentanyl matrix

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 Design

Study Type:

Observational

Actual Enrollment :

742 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

001

fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose)

Drug: fentanyl matrix

Knee osteoarthritis, starting with 12mcg/h (flexible dose)

002

fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose)

Drug: fentanyl matrix

Hip osteoarthritis, starting with 12mcg/h (flexible dose)

Outcome Measures

Primary Outcome Measures

Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale [Baseline and week 8]

Secondary Outcome Measures

Improved pain relief as measured using the K-WOMAC scale [baseline, week 4 and week 8]
Improvement of sleep disturbance [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 [baseline, week 4 and week 8]
Investigator and patient global assessment measured by 5-point likert scale [Week 4 and week 8]
Improved pain relief as measured using the CGI-I [Week 4 and week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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