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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01973790

Enrollment

207

Registered

2013-11-01

Start date

2014-03-31

Completion date

2017-04-30

Last updated

2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

Z-338, Functional Dyspepsia, Postprandial Distress Syndrome

Brief 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.

Detailed 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.

Interventions

DRUGZ-338

100mg TID

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
To explore the efficacy	up to 52 weeks	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.

Countries

Belgium, Bulgaria, Latvia, Lithuania, Romania, Russia, Slovakia, Sweden, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026