Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting
- Conditions
- Colon Cancer
- Interventions
- Registration Number
- NCT02076529
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Patients who recevied moderate emetogenic chemotherapy
- Age between 18-75
- ECOG PS 0-2
- Adequate organ fuction including bone marrow, liver and kidney
- Gastrointestinal obstruction or carcinomatosis peritonei
- CNS metastasis or disability in CNS
- Intractable medical illness
- Pregnancy or inadequate contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ramosetron 0.3mg Ramosetron 0.3mg Ramosetron 0.3mg intravenous injection 30 min before chemotherapy Ramosetron 0.6mg Ramosetron 0.6mg Ramosetron 0.6mg intravenous injection 30min before chemotherapy Ramosetron 0.45mg Ramosetron 0.45mg Ramosetron 0.45mg intravenous injection 30min before chemotherapy
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile of Ramosetron according to 3 level of dose 10min to 48 hours post-dose Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)
- Secondary Outcome Measures
Name Time Method Rhodes Index 1 hour to seven days post-dose Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection
Trial Locations
- Locations (1)
Chonnam National University Hwasun Hospital
🇰🇷Gwangju, Jeollanamdo, Korea, Republic of