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Completed

NCT Number: NCT00971399

Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

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).

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ramosetron

Drug

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

ondansetron

Drug

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

Primary outcomes

  1. complete response of RINV (no vomiting and no rescue medication)

    Time frame: 4 weeks after medication

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
First posted
Sep 3, 2009
Registry last updated
Feb 28, 2011

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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