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

Zeria Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Dyspepsia

Treatments

Drug: Z-338

Study type

Interventional

Funder types

Industry

Identifiers

NCT01973790

Z338-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

207 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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