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Completed

NCT Number: NCT00272285

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

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.

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Key information

Conditions

Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tainan, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron

Drug

IV, concomitant administration with dexamethasone

Granisetron

Drug

IV, concomitant administration with dexamethasone

Primary outcomes

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

    Time frame: 1 Day

Secondary outcomes

  1. Response rate of vomiting prevention

    Time frame: 1 Day

  2. The number of vomiting episodes

    Time frame: 1 Day

  3. The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jan 5, 2006
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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