Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

Chonnam National University

Status: Completed

Conditions: Colon Cancer

Treatments: Drug: Ramosetron 0.3mg; Drug: Ramosetron 0.6mg; Drug: Ramosetron 0.45mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02076529

RamosetronPK

Details and patient eligibility

About

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.

Full description

Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

Ramosetron 0.6mg

Experimental group

Description:

Ramosetron 0.6mg intravenous injection 30min before chemotherapy

Treatment:

Drug: Ramosetron 0.6mg

Ramosetron 0.45mg

Experimental group

Description:

Ramosetron 0.45mg intravenous injection 30min before chemotherapy

Treatment:

Drug: Ramosetron 0.45mg

Ramosetron 0.3mg

Active Comparator group

Description:

Ramosetron 0.3mg intravenous injection 30 min before chemotherapy

Treatment:

Drug: Ramosetron 0.3mg