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

NCT01119885 | Completed

• 1 other identifier: CR015454
• Study Type: observational
• Target: 742
• Locations: 0 countries
• Sites: N/A

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 \[tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)\].

Conditions

Pain; Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

chronic pain; fentanyl matrix; arthritis; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale

  Baseline and week 8

Secondary Outcomes (5)

• 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

Study Arms (2)

001

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

Drug: fentanyl matrix

002

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

Drug: fentanyl matrix

Interventions

fentanyl matrix DRUG

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

001

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Pain; Osteoarthritis, Hip; Osteoarthritis, Knee; Chronic Pain; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: May 10, 2010
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 28, 2014

Record last verified: 2014-04