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Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

NCT01536691 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2012-10-03

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Prospective multicenter, randomized, single blinded, phase III study.

Conditions

Interventions

DRUG

ramosetron

ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

DRUG

ondansetron

ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER

  • Astellas Pharma Korea, Inc.

    collaborator INDUSTRY

  • Hallym University Medical Center

    lead OTHER

Principal Investigators

  • Sangwon Shin, M.D. · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01536691 on ClinicalTrials.gov