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

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

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

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.

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