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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeria Pharmaceutical
• Treatments: Z 338

Criteria

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