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This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.
Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramosetron 0.6mg | Experimental | Ramosetron 0.6mg intravenous injection 30min before chemotherapy |
|
| Ramosetron 0.45mg | Experimental | Ramosetron 0.45mg intravenous injection 30min before chemotherapy |
|
| Ramosetron 0.3mg | Active Comparator | Ramosetron 0.3mg intravenous injection 30 min before chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron 0.3mg | Drug |
|
| |
| Ramosetron 0.45mg |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of Ramosetron according to 3 level of dose | Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr) | 10min to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Rhodes Index | Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection | 1 hour to seven days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hee Cho, M.D.Ph.D. | CNUHH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Gwangju | Jeollanamdo | 519-809 | South Korea |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
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| Drug |
|
|
| Ramosetron 0.6mg | Drug |
|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |