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NCT Number: NCT02076529

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hwasun Hospital

Gwangju, Jeollanamdo, 519-809, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron 0.3mg

Drug

Other names: Nasea 0.3mg

Ramosetron 0.45mg

Drug

Other names: Nasea 0.45mg

Ramosetron 0.6mg

Drug

Other names: Nasea 0.6mg

Primary outcomes

  1. Pharmacokinetic profile of Ramosetron according to 3 level of dose

    Time frame: 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 outcomes

  1. Rhodes Index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2014
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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