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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076529
• Other study ID #: RamosetronPK
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: February 28, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Cancer
• Vomiting

Intervention

Drug:
• Ramosetron 0.3mg

• Ramosetron 0.45mg

• Ramosetron 0.6mg

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Gwangju	Jeollanamdo

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No