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Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

NCT00971399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2011-02-28

No results posted yet for this study

Summary

The purpose of this study is:

1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
2. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).

Conditions

  • Radiotherapy Induced Nausea and Vomiting

Interventions

DRUG

ramosetron

ramosetron 0.1mg q.d. SL on D1-5

DRUG

ondansetron

ondansetron 8mg, b.i.d SL on D1-5

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971399 on ClinicalTrials.gov