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| ID | Type | Description | Link |
|---|---|---|---|
| FENPAI4094 | Other Identifier | Janssen Korea, Ltd., Korea | |
| FEN-KOR-5045 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl matrix | Drug | Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in mean pain intensity | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). | Baseline, Week 12 |
| The difference between the patient's pain treatment goal set at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andong | South Korea | |||||
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The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). |
| Baseline, Week 12 |
| The degree of night sleep disturbance due to pain | Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete. | 12 weeks |
| The degree of Interference with Daily Life Performance due to Pain | The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc. | 12 weeks |
| The degree of Interference with Social Life Performance due to Pain | The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc. | 12 weeks |
| The patient's global assessment of pain treatment | The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant. | 12 weeks |
| The investigator's global assessment of pain treatment | The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator. | 12 weeks |
| Busan |
| South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Goyang | South Korea |
| Incheon | South Korea |
| Jeonju | South Korea |
| Kwangiu | South Korea |
| Kwanju | South Korea |
| Seoul | South Korea |
| Wŏnju | South Korea |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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