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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02076529

Enrollment

Registered

2014-03-03

Start date

2012-10-31

Completion date

2013-12-31

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

chemotherapy induced nausea vomiting

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.

Interventions

DRUGRamosetron 0.3mg

DRUGRamosetron 0.45mg

DRUGRamosetron 0.6mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026