Phase III, Long-term, Open-label Safety Study of Z-338

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.

Detailed Description
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This is a Phase III, multicentre, single-arm, open-label study to evaluate the long-term safety of 100 mg Z-338 TID in subjects with FD. The study comprises a screening period (up to 3 weeks), a run-in period (1 week) and an open-label treatment period (52 weeks). Including an additional 2-week follow-up period for assessment of AEs, the maximum duration of a subject's participation in the study will be 58 weeks.

Official Title
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A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Z-338


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects to provide written informed consent prior to any study procedures being performed Subjects with a diagnosis of FD (postprandial distress syndrome) as defined by the Rome III Criteria Subjects must present Postprandial Fullness or Early Satiation as the most bothersome symptom during the 6 months prior to informed consent. Subjects must have a normal endoscopy result within the 6 months (3 months in case of subjects who are Helicobacter pylori positive) prior to informed consent or during the screening period. Exclusion Criteria: Subjects on PPI(s) who are unable to discontinue PPI medication by the end of the screening period Subjects taking drugs that affect gut motility, gut sensitivity and/or acid secretion who are unable to discontinue these drugs by the end of the screening period Subjects who have received H. pylori eradication therapy during the 3 months prior to informed consent Subjects with confirmed organic gastrointestinal disease Subjects presenting with predominant complaints relieved by stool movements (irritable bowel syndrome) Subjects presenting with predominant GORD symptoms Subjects presenting with predominant complaints of chronic idiopathic nausea Subjects with Type I or Type II diabetes Subjects with body mass index (BMI) over 30 kg/m2 Subjects with any condition which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-338<br>100mg TID | Drug: Z-338<br>* 100mg TID<br>* Other names: Acotiamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety endpoints | Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination | up to 58 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the efficacy | the use of LPDS to measure FD symptom severity and the effect of Z-338, the effect of Z-338 on the QoL in subjects with FD as measured by SF-36 survey and SF-NDI, the effect of Z-338 on work productivity in subjects with FD as measured by WPAI. | up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Z-338, Functional Dyspepsia, Postprandial Distress Syndrome