The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
207
100mg TID
General safety endpoints
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
Time frame: up to 58 weeks
To explore the efficacy
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.
Time frame: up to 52 weeks
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Zeria Investigative site
Leuven, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Liepāja, Latvia
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Limbaži, Latvia
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Riga, Latvia
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
...and 26 more locations