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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose) |
| |
| 002 | fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl matrix | Drug | Knee osteoarthritis, starting with 12mcg/h (flexible dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
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| fentanyl matrix |
| Drug |
Hip osteoarthritis, starting with 12mcg/h (flexible dose) |
|
| 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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| D059350 | Chronic Pain |
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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