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

September 2, 2009
February 24, 2011
September 2009
February 2011   (final data collection date for primary outcome measure)
complete response of RINV (no vomiting and no rescue medication) [ Time Frame: 4 weeks after medication ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971399 on ClinicalTrials.gov Archive Site
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Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Radiotherapy Induced Nausea and Vomiting
  • Drug: ramosetron
    ramosetron 0.1mg q.d. SL on D1-5
  • Drug: ondansetron
    ondansetron 8mg, b.i.d SL on D1-5
  • Experimental: RMS
    ramosetron 0.1mg q.d. SL on D1-5
    Intervention: Drug: ramosetron
  • Active Comparator: ODS
    ondansetron 8mg, b.i.d SL on D1-5
    Intervention: Drug: ondansetron
Kim K, Chie EK, Jang JY, Kim SW, Oh DY, Im SA, Kim TY, Bang YJ, Ha SW. Ramosetron for the prevention of nausea and vomiting during 5-fluorouracil-based chemoradiotherapy for pancreatico-biliary cancer. Jpn J Clin Oncol. 2009 Feb;39(2):111-5. Epub 2008 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00971399
RMS vs ODS for CRINV, 0808-011-252
No
Eui Kyu Chie/Assistant Clinical Professor, Department of Radiation Oncology, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP