Status:
RECRUITING
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04526119
Start Date
February 22 2021
End Date
June 1 2026
Last Update
July 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zeria Investigative Site
Matsumoto, Nagano, Japan