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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Dyspepsia

Clinical Trial Details

NCT number	NCT01973790
Study type	Interventional
Source	Zeria Pharmaceutical
Contact
Status	Completed
Phase	Phase 3
Start date	March 2014
Completion date	April 2017

View Details

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