Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip
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ClinicalTrials.gov Identifier: NCT01119885 |
Recruitment Status
:
Completed
First Posted
: May 10, 2010
Last Update Posted
: April 28, 2014
|
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Condition or disease | Intervention/treatment |
---|---|
Pain Osteoarthritis, Hip Osteoarthritis, Knee | Drug: fentanyl matrix |
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 |

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)
|
- Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale [ Time Frame: Baseline and week 8 ]
- Improved pain relief as measured using the K-WOMAC scale [ Time Frame: baseline, week 4 and week 8 ]
- Improvement of sleep disturbance [ Time Frame: 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 [ Time Frame: baseline, week 4 and week 8 ]
- Investigator and patient global assessment measured by 5-point likert scale [ Time Frame: Week 4 and week 8 ]
- Improved pain relief as measured using the CGI-I [ Time Frame: Week 4 and week 8 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119885
Study Director: | Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. |
Responsible Party: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT01119885 History of Changes |
Other Study ID Numbers: |
CR015454 |
First Posted: | May 10, 2010 Key Record Dates |
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 |