NCT00272285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

January 3, 2006

Last Update Submit

March 7, 2017

Conditions

VomitingNausea

Keywords

Serotonin antagonistsRandomized controlled trialCombination drug therapyDouble-blind method

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients without vomiting after the start of chemotherapy for 24 hours

    1 Day

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Intravenous (IV)

Drug: Ramosetron

2

ACTIVE COMPARATOR

Intravenous (IV)

Drug: Granisetron

Interventions

RamosetronDRUG

IV, concomitant administration with dexamethasone

1
GranisetronDRUG

IV, concomitant administration with dexamethasone

2

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, 105, Taiwan

Location

Related Links

MeSH Terms

Conditions

VomitingNausea

Interventions

ramosetronGranisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Use central contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 5, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

TW(2)