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