Long-term safety study of Z-338 in patients with functional dyspepsia
Research type
Research Study
Full title
A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects with Functional Dyspepsia
IRAS ID
147013
Contact name
Richard Gaunt
Contact email
Sponsor organisation
Zeria Pharmaceutical Co., Ltd.
Eudract number
2013-003342-16
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to find out if Z-338 is safe by looking at the long term effects of the drug being taken over a 52 week period in patients with meal related symptoms of Functional Dyspepsia. The Efficacy of the drug will also be measured. Z-338 increases movement of the stomach muscles. Approximately 350 patients will be dosed with Z-338. All patients will receive active study drug. The study will occur in 11 countries at approximately 65 sites in Europe. To take part, patients must be aged 18 years old or over and have meal related symptoms of Functional Dyspepsia. Participation in the study will involve 11 visits to the study clinic over a period of 55 to 58 weeks. There will be a screening/washout period (up to 3 weeks), a run in period (1 week), an Open Label treatment period (52 weeks) and a follow up period (2 weeks).
Assessments for the study will include physical examinations, blood and urine samples, questionnaires, ECG (electrical tracing of the heart), endoscopy (if this has not been performed in the last 3 – 6 months) and Helicobacter Pylori tests. Participants will be provided with a handheld electronic diary in which to record answers to questions each day. Patients who are currently taking Proton Pump Inhibitors (PPIs) or some other types of drug would need to stop taking these for at least 2 weeks before starting to take the study drug.
The study is sponsored by Zeria Pharmaceutical Co Ltd, with 3 GP practices in the UK taking part.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0795
Date of REC Opinion
9 Jun 2014
REC opinion
Favourable Opinion