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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119885
• Other study ID #: CR015454
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2010
• Last updated: April 24, 2014
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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)].

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale		Baseline and week 8	No
Secondary	Improved pain relief as measured using the K-WOMAC scale		baseline, week 4 and week 8	No
Secondary	Improvement of sleep disturbance		baseline, week 4 and week 8	No
Secondary	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	No
Secondary	Investigator and patient global assessment measured by 5-point likert scale		Week 4 and week 8	No
Secondary	Improved pain relief as measured using the CGI-I		Week 4 and week 8	No