NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-194691

Registered date:29/03/2019

A randomized, double-blind, multicenter, phase III study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving AC/EC based highly emetogenic chemotherapy

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedChemotherapy-induced nausea and vomiting
Date of first enrollment18/4/2019
Target sample size100
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Pro-NETU INN of the intervention : fosnetupitant Dosage And administration of the intervention : Pro-NETU 235 mg should be intravenously administered with drip infusion before the start of administration of highly emetogenic chemotherapy (HEC). Control intervention name : Fosaprepitant INN of the control intervention : Fosaprepitant Dosage And administration of the control intervention : Fosaprepitant 150 mg should be intravenously administered with drip infusion before the start of administration of HEC.

Outcome(s)

Primary Outcomesafety The incidence of side effect
Secondary Outcomesafety, efficacy Efficacy, Safety

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteria1. Patients who have provided written informed consent 2. Patients who are scheduled to be received cancer chemotherapy including the HEC agents (AC/EC) 3. ECOG performance status score of 0 to 1
Exclude criteria1. Patients with infection, diabetes mellitus, or other disease with difficultly to administer of dexamethasone, which is defined in the protocol 2. Patients who are unable or unwilling to cooperate in the implementation of study procedures (eg; writing a study report)

Related Information

Contact

public contact
Name Taiho Pharmaceutical Co., Ltd. Clinical Trial Registration Contact
Address -
Telephone -
E-mail toiawase@taiho.co.jp
Affiliation
scientific contact
Name Taiho Pharmaceutical Co., Ltd. Clinical Development Department
Address -
Telephone -
E-mail toiawaseCD1@taiho.co.jp
Affiliation