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Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy.
Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to ME chemotherapy).
The patch will be applied 2days (48-24h) prior to first daily dose of the moderately emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until 14 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sancuso patch | Experimental |
| |
| Kytril | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sancuso patch | Drug | Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen | from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients achieving Complete Response (CR) | overall (Day 1~4) | |
| The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen |
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Inclusion Criteria:
Exclusion Criteria:
A. Previous History
B. Concomitant Medical Condition
C. Concomitant Therapy/Medication
D. Other
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun-Ae Eom, BS | Contact | 82-2-6924-3157 | yaeom@lgls.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Seok Ahn, MD, PhD | Samsung Medical Center | Principal Investigator |
| Tae Won Kim, MD, PhD | Asan Medical Center | Principal Investigator |
| Dong Bok Shin, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25465680 | Derived | Kim JE, Hong YS, Lee JL, Kim KP, Park SJ, Sym SJ, Shin DB, Lee J, Park YS, Ahn JS, Kim TW. A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Support Care Cancer. 2015 Jun;23(6):1769-77. doi: 10.1007/s00520-014-2507-6. Epub 2014 Dec 3. |
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| Kytril inj.+Kytril tab. | Drug | Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Active Comparator arm:
|
|
| from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen |
| The percentage of patients achieving Complete Control (CC) | overall (Day 1~4) |
| severity of nausea | overall (Day 1~4) |
| severity of vomiting | overall (Day 1~4) |
| Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen | from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen |
| Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen | from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen |
| Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5) | The patient's response to anti-emetic therapy was assessed and recorded by patients at Visit 3 (Baseline) and Visit 7 (Day 5). The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines. | from baseline to Day 5 |
| The percentage of patients achieving Complete Response (CR) | per day (Day 1, 2, 3, 4) |
| The percentage of patients achieving Complete Control (CC) | per day (Day 1, 2, 3, 4) |
| severity of nausea | per day (Day 1, 2, 3, 4) |
| severity of vomiting | per day (Day 1, 2, 3, 4) |
| Gachon University Gil Medical Center |
| Principal Investigator |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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