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

Sponsor
Zeria Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04526119
Collaborator
(none)
100
1
2
49.2
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acotiamide hydrochloride hydrate
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Z-338 Phase III Trial - Evaluation of Pharmacokinetics, Efficacy and Safety in Paediatric Patients With Functional Dyspepsia
Actual Study Start Date :
Feb 22, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Z-338

Drug: Acotiamide 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

Placebo Comparator: Placebo

Drug: Placebo
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

Outcome Measures

Primary Outcome Measures

  1. Cmax of single dose Z-338 before meal [The 1 day of single dose]

  2. AUC up to 8 hours after administration of single dose Z-338 before meal [The 1 day of single dose]

  3. Elimination rate of three symptoms (Postprandial fullness, Upper abdominal bloating and Early satiation) [At week 4 of treatment or treatment discontinuation]

  4. Overall responder rate by the Overall Treatment Evaluation (OTE) scale [At week 4 of treatment or treatment discontinuation]

Secondary Outcome Measures

  1. Elimination rate of each symptom [Weekly from the day of randomization to Week 8]

  2. Average severity score of each symptom [Weekly from the day of randomization to Week 8]

  3. Worst severity score of each symptom [Weekly from the day of randomization to Week 8]

  4. Weekly responder rate by the OTE scale [Weekly from the day of randomization to Week 8]

  5. Incidence of adverse events [8-weeks study period]

  6. Incidence of adverse drug reactions [8-weeks study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zeria Investigative Site Matsumoto Nagano Japan

Sponsors and Collaborators

  • Zeria Pharmaceutical

Investigators

  • Study Director: Tomoharu Miyagawa, Zeria Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT04526119
Other Study ID Numbers:
  • Z-338-07
First Posted:
Aug 25, 2020
Last Update Posted:
Mar 25, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2021