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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

NCT01536691

Cancer Malignancy

UNKNOWN PHASE3

Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer

NCT01046461

Solid Tumour Postoperative Nausea and Vomiting

UNKNOWN PHASE2

The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV

NCT05690802

Nausea and Vomiting

RECRUITING NA

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

NCT00666783

Chemotherapy-Induced Nausea and Vomiting

COMPLETED PHASE2

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

NCT04592198

Nausea With Vomiting Chemotherapy-Induced

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ramosetron 0.6mg

Ramosetron 0.6mg intravenous injection 30min before chemotherapy

Group Type EXPERIMENTAL

Ramosetron 0.6mg

Intervention Type DRUG

Ramosetron 0.45mg

Ramosetron 0.45mg intravenous injection 30min before chemotherapy

Group Type EXPERIMENTAL

Ramosetron 0.45mg

Intervention Type DRUG

Ramosetron 0.3mg

Ramosetron 0.3mg intravenous injection 30 min before chemotherapy

Group Type ACTIVE_COMPARATOR

Ramosetron 0.3mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ramosetron 0.3mg

Intervention Type DRUG

Ramosetron 0.45mg

Intervention Type DRUG

Ramosetron 0.6mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nasea 0.3mg Nasea 0.45mg Nasea 0.6mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No