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| ID | Type | Description | Link |
|---|---|---|---|
| FEN-KOR-13 |
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The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl D-trans | Drug | Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Satisfied With Pain Treatment | Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain. | Day 1 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other. | Day 29 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Initial and End Point Dose of TTS-Fentanyl D-trans | Dose of TTS-fentanyl D-trans were monitored at start and end of the trial. | Day 1 and Day 29 |
| Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied. | Day 29 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Out of a total of 103 participants, data for baseline characteristic (age) was available only for 98 participants. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Out of a total of 103 participants, data for baseline characteristic (gender) was available only for 98 participants. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Satisfied With Pain Treatment | Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans. | Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
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| Secondary | Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain. | Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 29 |
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| Other Pre-specified | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other. | Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Day 29 |
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| Other Pre-specified | Initial and End Point Dose of TTS-Fentanyl D-trans | Dose of TTS-fentanyl D-trans were monitored at start and end of the trial. | Safety population included all participants who were administered the TTS-fentanyl D-trans at least once. | Posted | Mean | Standard Deviation | microgram per hour (mcg/hr) | Day 1 and Day 29 |
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| Other Pre-specified | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied. | Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Day 29 |
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Day 1 to Day 29
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transdermal Therapeutic System (TTS)-Fentanyl D-trans | Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. | 18 | 103 | 25 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Disease Progression | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Abdominal distention | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
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| Gallbladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
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| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
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| Camptocormia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cerebral infraction | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cervical cord compression | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRA | Medical affairs, Janssen Korea, Ltd. | 82220944835 |
| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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