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The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl matrix | Drug | Fentanyl transdermal patch 12 - 25mcg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's satisfaction with pain treatment as measured by 5-point verbal scale | Day 1, 8 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured | Day 1 (visit 1) and 22 (visit 3) | |
| Detailed reasons for patient's satisfaction with the pain treatment | Day 22 (visit 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug | Day 22 (visit 3) |
| Dose of fentanyl matrix | Day 1 (visit 1), 8 (visit 2) and 22 (visit 3) |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |