This trial is active, not recruiting.

Condition dyspepsia
Treatment z-338
Phase phase 3
Sponsor Zeria Pharmaceutical
Start date March 2014
End date February 2017
Trial size 207 participants
Trial identifier NCT01973790, Z338-01


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
100mg TID
z-338 Acotiamide
100mg TID

Primary Outcomes

General safety endpoints
time frame: up to 58 weeks

Secondary Outcomes

To explore the efficacy
time frame: up to 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia
Principal investigator Jan Tack, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Zeria Pharmaceutical.