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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Pain; Osteoarthritis, Hip; Osteoarthritis, Knee	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

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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 :	August 2008
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
002; fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose)	Drug: fentanyl matrix; Hip osteoarthritis, starting with 12mcg/h (flexible dose)

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Improved pain relief as measured using the K-WOMAC scale [ Time Frame: baseline, week 4 and week 8 ]
2. Improvement of sleep disturbance [ Time Frame: baseline, week 4 and week 8 ]
3. 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 ]
4. Investigator and patient global assessment measured by 5-point likert scale [ Time Frame: Week 4 and week 8 ]
5. Improved pain relief as measured using the CGI-I [ Time Frame: Week 4 and week 8 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:	Janssen Korea, Ltd. Clinical Trial	Janssen Korea, Ltd.

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT01119885 History of Changes
Other Study ID Numbers:	CR015454
First Posted:	May 10, 2010
Last Update Posted:	April 28, 2014
Last Verified:	April 2014

Keywords provided by Janssen Korea, Ltd., Korea:

chronic pain; fentanyl matrix; arthritis; osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fentanyl; Analgesics, Opioid; Narcotics	Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics