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

NCT01973790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2017-06-28

No results posted yet for this study

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.

Conditions

  • Dyspepsia

Interventions

DRUG

Z-338

100mg TID

Sponsors & Collaborators

  • Zeria Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Jan Tack, MD, PhD · University of Leuven, University Hospital Gasthuisberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-11-30
Completion
2017-04-30

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973790 on ClinicalTrials.gov