NCT01973790

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Z-338	100mg TID

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-11-01
• Completion: 2017-04-01
• First posted: 2013-11-01
• Last updated: 2017-06-28

Locations

36 sites across 10 countries: Belgium, Bulgaria, Latvia, Lithuania, Romania, Russia, Slovakia, Sweden, Ukraine, United Kingdom