Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting
A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
1 other identifier
interventional
51
1 country
1
Brief Summary
This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedMarch 3, 2014
February 1, 2014
1.2 years
February 28, 2014
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic profile of Ramosetron according to 3 level of dose
Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)
10min to 48 hours post-dose
Secondary Outcomes (1)
Rhodes Index
1 hour to seven days post-dose
Study Arms (3)
Ramosetron 0.6mg
EXPERIMENTALRamosetron 0.6mg intravenous injection 30min before chemotherapy
Ramosetron 0.45mg
EXPERIMENTALRamosetron 0.45mg intravenous injection 30min before chemotherapy
Ramosetron 0.3mg
ACTIVE COMPARATORRamosetron 0.3mg intravenous injection 30 min before chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Patients who recevied moderate emetogenic chemotherapy
- Age between 18-75
- ECOG PS 0-2
- Adequate organ fuction including bone marrow, liver and kidney
You may not qualify if:
- Gastrointestinal obstruction or carcinomatosis peritonei
- CNS metastasis or disability in CNS
- Intractable medical illness
- Pregnancy or inadequate contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonnam National University Hwasun Hospital
Gwangju, Jeollanamdo, 519-809, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Hee Cho, M.D.Ph.D.
CNUHH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 3, 2014
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 3, 2014
Record last verified: 2014-02