Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971399

Enrollment

172

Registered

2009-09-03

Start date

2009-09-30

Completion date

Unknown

Last updated

2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy Induced Nausea and Vomiting

Brief 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).

Interventions

DRUGramosetron

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

DRUGondansetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* AJCC 1-3 staged gastrointestinal cancer patient * patient undergoing radiotherapy as treatment * age 20 yr and higher * ECOG 0-2

Exclusion criteria

* age \< 20 * ECOG 3-4 * patient experiencing nausea or vomiting prior to accrual * patient under antiemetic medication * patient under steroid medication (topical or inhalant steroid application are exceptional) * patient under opioid medication

Design outcomes

Primary

Measure	Time frame
complete response of RINV (no vomiting and no rescue medication)	4 weeks after medication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026