An observational study in Pain, Osteoarthritis, Hip and Osteoarthritis, Knee, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-04-28.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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)].
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
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 742 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose)
Drug: fentanyl matrix
Knee osteoarthritis, starting with 12mcg/h (flexible dose)
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
No study locations are listed for this record.
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Janssen Korea, Ltd., Korea