Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting - Full Text View

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:	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:

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:	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

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:

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:	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 February 09, 2012