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

Purpose

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	Intervention	Phase
Pain Osteoarthritis, Hip Osteoarthritis, Knee	Drug: fentanyl matrix	Phase 4


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved pain relief as measured using the K-WOMAC scale [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
Improvement of sleep disturbance [ Time Frame: baseline, week 4 and week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Investigator and patient global assessment measured by 5-point likert scale [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: No ]
Improved pain relief as measured using the CGI-I [ Time Frame: Week 4 and week 8 ] [ Designated as safety issue: No ]


Enrollment:	742
Study Start Date:	August 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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)

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

Eligibility


Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119885

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators


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

More Information

No publications provided


Responsible Party:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT01119885 History of Changes
Other Study ID Numbers:	CR015454
Study First Received:	January 29, 2010
Last Updated:	April 24, 2014
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:


chronic pain fentanyl matrix arthritis osteoarthritis

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015