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
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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