Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

This study is currently recruiting participants.

Verified by Seoul National University Hospital, September 2009

First Received: September 2, 2009 No Changes Posted

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00971399

Purpose

The purpose of this study is:

To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Ramosetron YM 060

U.S. FDA Resources

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:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RMS: Experimental ramosetron 0.1mg q.d. SL on D1-5	Drug: ramosetron ramosetron 0.1mg q.d. SL on D1-5
ODS: Active Comparator 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

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

Contacts

Contact: Eui Kyu Chie, MD

82-2-2072-3705

ekchie93@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Eui Kyu Chie, MD
Sub-Investigator: Yung-Jue Bang, MD
Sub-Investigator: Tae-You Kim, MD
Sub-Investigator: Seock-Ah Im, MD
Sub-Investigator: Do-Youn Oh, MD
Sub-Investigator: Se-Won Han, MD

Sponsors and Collaborators

Seoul National University Hospital

More Information

Publications:

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.

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Signs and Symptoms
Serotonin Antagonists
Neoplasms by Site
Therapeutic Uses
Antipruritics
Nausea
Ondansetron

Dermatologic Agents
Tranquilizing Agents
Digestive System Neoplasms
Gastrointestinal Agents
Central Nervous System Depressants
Ramosetron
Antipsychotic Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Serotonin Agents
Autonomic Agents
Gastrointestinal Neoplasms
Anti-Anxiety Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010