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

February 28, 2014 updated by: Sang-Hee Cho, Chonnam National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollanamdo
      • Gwangju, Jeollanamdo, Korea, Republic of, 519-809
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ramosetron 0.6mg
Ramosetron 0.6mg intravenous injection 30min before chemotherapy
Drug: Ramosetron 0.6mg
Other Names:
  • Nasea 0.6mg
EXPERIMENTAL: Ramosetron 0.45mg
Ramosetron 0.45mg intravenous injection 30min before chemotherapy
Drug: Ramosetron 0.45mg
Other Names:
  • Nasea 0.45mg
ACTIVE_COMPARATOR: Ramosetron 0.3mg
Ramosetron 0.3mg intravenous injection 30 min before chemotherapy
Drug: Ramosetron 0.3mg
Other Names:
  • Nasea 0.3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10min to 48 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour to seven days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RamosetronPK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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