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

Phase 3

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Z-338

• Registration Number: NCT01973790
• Lead Sponsor: Zeria Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-01
• Study Start: 2014-03
• Primary Completion: 2016-11
• Status Verified: 2017-01
• Study Completion: 2017-04
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Z-338	Z-338	100mg TID

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Zeria Investivgative SIte; 🇱🇻 Limbazi, Latvia

Zeria Invetigative Site; 🇱🇻 Liepaja, Latvia

Zeria Investigative Sites; 🇸🇪 Stockholm, Sweden

Zeria Investigative site; 🇬🇧 Bath, United Kingdom

Zeria Investigative Site; 🇬🇧 Leamington Spa, United Kingdom

Zeria Investigative sites; 🇸🇰 Kosice, Slovakia