Phase III, Long-term, Open-label Safety Study of Z-338
A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia
1 other identifier
interventional
207
10 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2014
Typical duration for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJune 28, 2017
January 1, 2017
2.7 years
October 26, 2013
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
General safety endpoints
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
up to 58 weeks
Secondary Outcomes (1)
To explore the efficacy
up to 52 weeks
Study Arms (1)
Z-338
EXPERIMENTAL100mg TID
Interventions
Eligibility Criteria
You may qualify if:
- Subjects to provide written informed consent prior to any study procedures being performed
- Subjects with a diagnosis of FD (postprandial distress syndrome) as defined by the Rome III Criteria
- Subjects must present Postprandial Fullness or Early Satiation as the most bothersome symptom during the 6 months prior to informed consent.
- Subjects must have a normal endoscopy result within the 6 months (3 months in case of subjects who are Helicobacter pylori positive) prior to informed consent or during the screening period.
You may not qualify if:
- Subjects on PPI(s) who are unable to discontinue PPI medication by the end of the screening period
- Subjects taking drugs that affect gut motility, gut sensitivity and/or acid secretion who are unable to discontinue these drugs by the end of the screening period
- Subjects who have received H. pylori eradication therapy during the 3 months prior to informed consent
- Subjects with confirmed organic gastrointestinal disease
- Subjects presenting with predominant complaints relieved by stool movements (irritable bowel syndrome)
- Subjects presenting with predominant GORD symptoms
- Subjects presenting with predominant complaints of chronic idiopathic nausea
- Subjects with Type I or Type II diabetes
- Subjects with body mass index (BMI) over 30 kg/m2
- Subjects with any condition which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Zeria Investigative site
Leuven, Belgium
Zeria Investigative Site
Plovdiv, Bulgaria
Zeria Investigative Sites
Sofia, Bulgaria
Zeria Investigative site
Varna, Bulgaria
Zeria Invetigative Site
Liepāja, Latvia
Zeria Investivgative SIte
Limbaži, Latvia
Zeria Investigative Sites
Riga, Latvia
Zeria Investigative Site
Alytus, Lithuania
Zeria Investigative Sites
Kaunas, Lithuania
Zeria Investigative Site
Klaipėda, Lithuania
Zeria Investigative Site
Vilnius, Lithuania
Zeria Investigative Site
Brasov, Romania
Zeria Investigative Sites
Bucharest, Romania
Zeria Investigative Sites
Cluj-Napoca, Romania
Zeria Investigative Site
Sibiu, Romania
Zeria Investigative Site
Târgu Mureş, Romania
Zeria Investigative Sites
Timișoara, Romania
Zeria Investigative Site
Kazan', Russia
Zeria Investigative Site
Ryazan, Russia
Zeria Investigative Site
Saratov, Russia
Zeria Investigative Site
Yaroslavl, Russia
Zeria Investigative sites
Bratislava, Slovakia
Zeria Investigative sites
Košice, Slovakia
Zeria Investigative Site
Malacky, Slovakia
Zeria Investigative Site
Martin, Slovakia
Zeria Investigative Site
Nitra, Slovakia
Zeria Investigative Site
Prešov, Slovakia
Zeria Investigative Site
Trnava, Slovakia
Zeria Investigative Site
Gothenburg, Sweden
Zeria Investigative Sites
Stockholm, Sweden
Zeria Investigative Site
Dnipropetrovsk, Ukraine
Zeria Investigative Site
Kyiv, Ukraine
Zeria Investigative Site
Vinnytsia, Ukraine
Zeria Investigative site
Barnstaple, United Kingdom
Zeria Investigative site
Bath, United Kingdom
Zeria Investigative Site
Royal Leamington Spa, United Kingdom
Related Publications (1)
Tack J, Pokrotnieks J, Urbonas G, Banciu C, Yakusevich V, Bunganic I, Tornblom H, Kleban Y, Eavis P, Tsuchikawa M, Miyagawa T. Long-term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)-results from the European phase 3 open-label safety trial. Neurogastroenterol Motil. 2018 Jun;30(6):e13284. doi: 10.1111/nmo.13284. Epub 2018 Jan 8.
PMID: 29315999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Tack, MD, PhD
University of Leuven, University Hospital Gasthuisberg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2013
First Posted
November 1, 2013
Study Start
March 1, 2014
Primary Completion
November 1, 2016
Study Completion
April 1, 2017
Last Updated
June 28, 2017
Record last verified: 2017-01