Colon Cancer Clinical Trial
Official title:
A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
Verified date | February 2014 |
Source | Chonnam National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients who recevied moderate emetogenic chemotherapy - Age between 18-75 - ECOG PS 0-2 - Adequate organ fuction including bone marrow, liver and kidney Exclusion Criteria: - Gastrointestinal obstruction or carcinomatosis peritonei - CNS metastasis or disability in CNS - Intractable medical illness - Pregnancy or inadequate contraception |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hwasun Hospital | Gwangju | Jeollanamdo |
Lead Sponsor | Collaborator |
---|---|
Chonnam National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Rhodes Index | Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection | 1 hour to seven days post-dose | No |
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