A Phase III Trial of Z-338 in Paediatric Patients with Functional Dyspepsia
- Conditions
- Functional Dyspepsia
- Registration Number
- JPRN-jRCT2080225344
- Lead Sponsor
- Zeria Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 100
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).
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Cmax and AUC up to 8 hours after administration of single dose Z-338 before meal<br>efficacy<br>Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation) at week 4 of treatment or treatment discontinuation<br>efficacy<br>Overall responder rate by the Overall Treatment Evaluation (OTE) scale at week 4 of treatment or treatment discontinuation
- Secondary Outcome Measures
Name Time Method efficacy<br>Weekly elimination rate, weekly average severity score and weekly worst severity score of each symptom<br>efficacy<br>Weekly reponder rate by the OTE scale<br>safety<br>Incidence of adverse events<br>safety<br>Incidence of adverse drug reactions