Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: Ramosetron 0.3mg
* Drug: Ramosetron 0.45mg
* Drug: Ramosetron 0.6mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who recevied moderate emetogenic chemotherapy Age between 18-75 ECOG PS 0-2 Adequate organ fuction including bone marrow, liver and kidney Exclusion Criteria: Gastrointestinal obstruction or carcinomatosis peritonei CNS metastasis or disability in CNS Intractable medical illness Pregnancy or inadequate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramosetron 0.6mg<br>Ramosetron 0.6mg intravenous injection 30min before chemotherapy | Drug: Ramosetron 0.6mg<br> <br> * Other names: Nasea 0.6mg;|
| Experimental: Ramosetron 0.45mg<br>Ramosetron 0.45mg intravenous injection 30min before chemotherapy | Drug: Ramosetron 0.45mg<br> <br> * Other names: Nasea 0.45mg;|
| Active Comparator: Ramosetron 0.3mg<br>Ramosetron 0.3mg intravenous injection 30 min before chemotherapy | Drug: Ramosetron 0.3mg<br> <br> * Other names: Nasea 0.3mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy induced nausea vomiting