Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00971399
First received: September 2, 2009
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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).

Condition Intervention Phase
Radiotherapy Induced Nausea and Vomiting
Drug: ramosetron
Drug: ondansetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • complete response of RINV (no vomiting and no rescue medication) [ Time Frame: 4 weeks after medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: September 2009
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RMS
ramosetron 0.1mg q.d. SL on D1-5
Drug: ramosetron
ramosetron 0.1mg q.d. SL on D1-5
Active Comparator: ODS
ondansetron 8mg, b.i.d SL on D1-5
Drug: ondansetron
ondansetron 8mg, b.i.d SL on D1-5

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971399

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications:
Responsible Party: Eui Kyu Chie/Assistant Clinical Professor, Department of Radiation Oncology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00971399     History of Changes
Other Study ID Numbers: RMS vs ODS for CRINV, 0808-011-252
Study First Received: September 2, 2009
Last Updated: February 24, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Vomiting
Gastrointestinal Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Ondansetron
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014