A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea

A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272285

Enrollment

287

Registered

2006-01-05

Start date

2006-01-31

Completion date

2008-03-31

Last updated

2017-03-09

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

Conditions

Nausea, Vomiting

Keywords

Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method

Brief summary

The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.

Interventions

DRUGRamosetron

IV, concomitant administration with dexamethasone

DRUGGranisetron

IV, concomitant administration with dexamethasone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Subject with age between 20-74 years old (inclusive) of either sex * Cancer subject is scheduled to receive the designated chemotherapy programs * Subject without symptoms of vomiting for at least one week before dosing trial medication * Subject with ECOG performance status scale no greater than 2 * Subject has signed the written informed consent form

Exclusion criteria

* Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study * Subject has received the designated chemotherapy programs within 6 months before entering the study * Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening * Subject has known concurrent diseases that may cause vomiting * Subject has taken medications that could influence the outcome of the study within 3 days before entering the study * Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone * Female subject who is pregnant or breastfeeding * Subject with life expectancy less than 3 months * Subject participated other investigational drug trial within 1 month before entering this study

Design outcomes

Primary

Measure	Time frame
Proportion of patients without vomiting after the start of chemotherapy for 24 hours	1 Day

Secondary

Measure	Time frame
Response rate of vomiting prevention	1 Day
The number of vomiting episodes	1 Day
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)	1 Day

Countries

Taiwan

Outcome results

None listed

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