Functional Dyspepsia
Conditions
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.
Interventions
DRUGAcotiamide hydrochloride hydrate
A white film-coated tablet containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase Administered orally, one tablet a time and three times a day before meals for 28 days in the open-label phase
DRUGPlacebo
A white film-coated tablet not containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of single dose Z-338 before meal | The 1 day of single dose |
| AUC up to 8 hours after administration of single dose Z-338 before meal | The 1 day of single dose |
| Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation) | At week 4 of treatment or treatment discontinuation |
| Overall responder rate by the Overall Treatment Evaluation (OTE) scale | At week 4 of treatment or treatment discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Elimination rate of each symptom | Weekly from the day of randomization to Week 8 |
| Average severity score of each symptom | Weekly from the day of randomization to Week 8 |
| Worst severity score of each symptom | Weekly from the day of randomization to Week 8 |
| Weekly responder rate by the OTE scale | Weekly from the day of randomization to Week 8 |
| Incidence of adverse events | 8-weeks study period |
| Incidence of adverse drug reactions | 8-weeks study period |
Countries
Japan
Contacts
STUDY_DIRECTORYuji Shibasaki
Zeria Pharmaceutical
Outcome results
None listed