Clinical trial NCT01973790: Phase III, Long-term, Open-label Safety Study of Z-338
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Z-338
Functional Dyspepsia
Postprandial Distress Syndrome
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-11-01
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: General safety endpoints
timeFrame: up to 58 weeks
Secondary outcomes:
measure: To explore the efficacy
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Zeria Investigative site
city: Plovdiv
country: Bulgaria
facility: Zeria Investigative Site
city: Sofia
country: Bulgaria
facility: Zeria Investigative Sites
city: Varna
country: Bulgaria
facility: Zeria Investigative site
city: Liepaja
country: Latvia
facility: Zeria Invetigative Site
city: Limbazi
country: Latvia
facility: Zeria Investivgative SIte
city: Riga
country: Latvia
facility: Zeria Investigative Sites
city: Alytus
country: Lithuania
facility: Zeria Investigative Site
city: Kaunas
country: Lithuania
facility: Zeria Investigative Sites
city: Klaipeda
country: Lithuania
facility: Zeria Investigative Site
city: Vilnius
country: Lithuania
facility: Zeria Investigative Site
city: Brasov
country: Romania
facility: Zeria Investigative Site
city: Bucharest
country: Romania
facility: Zeria Investigative Sites
city: Cluj-Napoca
country: Romania
facility: Zeria Investigative Sites
city: Sibiu
country: Romania
facility: Zeria Investigative Site
city: Timisoara
country: Romania
facility: Zeria Investigative Sites
city: Tirgu Mures
country: Romania
facility: Zeria Investigative Site
city: Kazan
country: Russian Federation
facility: Zeria Investigative Site
city: Ryazan
country: Russian Federation
facility: Zeria Investigative Site
city: Saratov
country: Russian Federation
facility: Zeria Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Zeria Investigative Site
city: Bratislava
country: Slovakia
facility: Zeria Investigative sites
city: Kosice
country: Slovakia
facility: Zeria Investigative sites
city: Malacky
country: Slovakia
facility: Zeria Investigative Site
city: Martin
country: Slovakia
facility: Zeria Investigative Site
city: Nitra
country: Slovakia
facility: Zeria Investigative Site
city: Presov
country: Slovakia
facility: Zeria Investigative Site
city: Trnava
country: Slovakia
facility: Zeria Investigative Site
city: Gothenburg
country: Sweden
facility: Zeria Investigative Site
city: Stockholm
country: Sweden
facility: Zeria Investigative Sites
city: Dnipropetrovsk
country: Ukraine
facility: Zeria Investigative Site
city: Kyiv
country: Ukraine
facility: Zeria Investigative Site
city: Vinnytsya
country: Ukraine
facility: Zeria Investigative Site
city: Barnstaple
country: United Kingdom
facility: Zeria Investigative site
city: Bath
country: United Kingdom
facility: Zeria Investigative site
city: Leamington Spa
country: United Kingdom
facility: Zeria Investigative Site
Study officials:
affiliation: University of Leuven, University Hospital Gasthuisberg
name: Jan Tack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.