Phase III, Long-term, Open-label Safety Study of Z-338
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|ClinicalTrials.gov Identifier: NCT01973790|
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Z-338||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||April 2017|
Other Name: Acotiamide
- General safety endpoints [ Time Frame: up to 58 weeks ]Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
- To explore the efficacy [ Time Frame: up to 52 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973790
|Principal Investigator:||Jan Tack, MD, PhD||University of Leuven, University Hospital Gasthuisberg|