NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080225344

Registered date:25/08/2020

A Phase III Trial of Z-338 in Paediatric Patients with Functional Dyspepsia

Basic Information

Recruitment status recruiting
Health condition(s) or Problem(s) studiedFunctional Dyspepsia
Date of first enrollment22/02/2021
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : Acotiamide hydrochloride hydrate INN of investigational material : acotiamide Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : In Part 1, a single oral dose of Z-338 100 mg is administered before meal. In Part 2, oral dose of Z-338 100 mg are administered 3 times daily before meals. control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo are not administered in Part 1. Oral dose of placebo are administered 3 times daily before meals in only double-blind phase of Part 2.

Outcome(s)

Primary Outcomepharmacokinetics Cmax and AUC up to 8 hours after administration of single dose Z-338 before meal efficacy Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation) at week 4 of treatment or treatment discontinuation efficacy Overall responder rate by the Overall Treatment Evaluation (OTE) scale at week 4 of treatment or treatment discontinuation
Secondary Outcomeefficacy Weekly elimination rate, weekly average severity score and weekly worst severity score of each symptom efficacy Weekly reponder rate by the OTE scale safety Incidence of adverse events safety Incidence of adverse drug reactions

Key inclusion & exclusion criteria

Age minimum>= 9age old
Age maximum<= 17age old
GenderBoth
Include criteriaMain Inclusion Criteria - Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the day the informed consent is signed. - Subjects with a diagnosis of FD as defined by the Rome IV Criteria. - Subjects who have postprandial fullness, upper abdominal bloating or early satiation as the most bothersome symptom. - Subjects who have postprandial fullness, upper abdominal bloating or early satiation of a certain severity during one week prior to the day of randomization (Part 2 only).
Exclude criteriaMain Exclusion Criteria - Subjects who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent. - Subjects who have received Helicobacter pylori eradication therapy within 24 weeks prior to informed consent, or subjects who is defined as Helicobacter pylori-positive within 4 weeks prior to or on the day the informed consent is signed. - Subjects who have alarm symptom on the day the informed consent is signed. - Subjects who have food allergy of unknown origin or uncontrolled food allergy. - Subjects taking drugs used for functional dyspepsia within 2 weeks prior to the day of randomization (excluding proton pump inhibitors) (Part 2 only). - Subjects taking proton pump inhibitors within 4 weeks prior to the day of randomization (Part 2 only).

Related Information

Contact

Public contact
Name
Address 10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo.
Telephone
E-mail
Affiliation Zeria Pharmaceutical Co., Ltd.
Scientific contact
Name
Address 10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo.
Telephone
E-mail
Affiliation Zeria Pharmaceutical Co., Ltd.