Clinical trial NCT04526119: A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Official title: Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD).

In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated.

In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated.

Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days.


Eligibility criteria: Main Inclusion Criteria:

Part 1\& Part 2

* 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.

Part 2 only

* Subjects who have postprandial fullness, upper abdominal bloating or early satiation during with a certain severity during a week prior to the day of randomization.

Main Exclusion Criteria:

Part 1\&Part 2

* Subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
* Subject 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.

Part 2 only

* Subject taking drugs used for FD within 2 weeks prior to the day of randomization (excluding proton pump inhibitors)
* Subject taking proton pump inhibitors within 4 weeks prior to the day of randomization.

Primary outcomes:
measure: Cmax of single dose Z-338 before meal
timeFrame: The 1 day of single dose
measure: AUC up to 8 hours after administration of single dose Z-338 before meal
timeFrame: The 1 day of single dose
measure: Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation)
timeFrame: At week 4 of treatment or treatment discontinuation
measure: Overall responder rate by the Overall Treatment Evaluation (OTE) scale
timeFrame: At week 4 of treatment or treatment discontinuation
Secondary outcomes:
measure: Elimination rate of each symptom
timeFrame: Weekly from the day of randomization to Week 8
measure: Average severity score of each symptom
timeFrame: Weekly from the day of randomization to Week 8
measure: Worst severity score of each symptom
timeFrame: Weekly from the day of randomization to Week 8
measure: Weekly responder rate by the OTE scale
timeFrame: Weekly from the day of randomization to Week 8
measure: Incidence of adverse events
timeFrame: 8-weeks study period
measure: Incidence of adverse drug reactions
timeFrame: 8-weeks study period
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Zeria Investigative Site
state: Nagano
Study officials:
affiliation: Zeria Pharmaceutical
name: Yuji Shibasaki
role: STUDY_DIRECTOR
References: