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

JRCT ID: jRCT2080225344

Registered date:25/08/2020

Basic Information

• Recruitment status: recruiting
• Health condition(s) or Problem(s) studied: Functional Dyspepsia
• Date of first enrollment: 22/02/2021
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome

pharmacokinetics
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 Outcome

efficacy
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
• Gender: Both

Include criteria

Main 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 criteria

Main 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

• Primary Sponsor: Zeria Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT04526119,JapicCTI-205440