Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Radiotherapy Induced Nausea and Vomiting Clinical Trial

Official title: Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Radiotherapy Induced Nausea and Vomiting
• Vomiting

• NCT number: NCT00971399
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: Phase 3
• Start date: September 2009