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

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Z-338
Sponsored by
Zeria Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Z-338, Functional Dyspepsia, Postprandial Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zeria Investigative site
  • Zeria Investigative Site
  • Zeria Investigative Sites
  • Zeria Investigative site
  • Zeria Invetigative Site
  • Zeria Investivgative SIte
  • Zeria Investigative Sites
  • Zeria Investigative Site
  • Zeria Investigative Sites
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Sites
  • Zeria Investigative Sites
  • Zeria Investigative Site
  • Zeria Investigative Sites
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative sites
  • Zeria Investigative sites
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Sites
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative Site
  • Zeria Investigative site
  • Zeria Investigative site
  • Zeria Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Z-338

Arm Description

100mg TID

Outcomes

Primary Outcome Measures

General safety endpoints
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination

Secondary Outcome Measures

To explore the efficacy
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.

Full Information

First Posted
October 26, 2013
Last Updated
June 27, 2017
Sponsor
Zeria Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01973790
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Z-338, Functional Dyspepsia, Postprandial Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Z-338
Arm Type
Experimental
Arm Description
100mg TID
Intervention Type
Drug
Intervention Name(s)
Z-338
Other Intervention Name(s)
Acotiamide
Intervention Description
100mg TID
Primary Outcome Measure Information:
Title
General safety endpoints
Description
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
Time Frame
up to 58 weeks
Secondary Outcome Measure Information:
Title
To explore the efficacy
Description
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.
Time Frame
up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, MD, PhD
Organizational Affiliation
University of Leuven, University Hospital Gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeria Investigative site
City
Leuven
Country
Belgium
Facility Name
Zeria Investigative Site
City
Plovdiv
Country
Bulgaria
Facility Name
Zeria Investigative Sites
City
Sofia
Country
Bulgaria
Facility Name
Zeria Investigative site
City
Varna
Country
Bulgaria
Facility Name
Zeria Invetigative Site
City
Liepaja
Country
Latvia
Facility Name
Zeria Investivgative SIte
City
Limbazi
Country
Latvia
Facility Name
Zeria Investigative Sites
City
Riga
Country
Latvia
Facility Name
Zeria Investigative Site
City
Alytus
Country
Lithuania
Facility Name
Zeria Investigative Sites
City
Kaunas
Country
Lithuania
Facility Name
Zeria Investigative Site
City
Klaipeda
Country
Lithuania
Facility Name
Zeria Investigative Site
City
Vilnius
Country
Lithuania
Facility Name
Zeria Investigative Site
City
Brasov
Country
Romania
Facility Name
Zeria Investigative Sites
City
Bucharest
Country
Romania
Facility Name
Zeria Investigative Sites
City
Cluj-Napoca
Country
Romania
Facility Name
Zeria Investigative Site
City
Sibiu
Country
Romania
Facility Name
Zeria Investigative Sites
City
Timisoara
Country
Romania
Facility Name
Zeria Investigative Site
City
Tirgu Mures
Country
Romania
Facility Name
Zeria Investigative Site
City
Kazan
Country
Russian Federation
Facility Name
Zeria Investigative Site
City
Ryazan
Country
Russian Federation
Facility Name
Zeria Investigative Site
City
Saratov
Country
Russian Federation
Facility Name
Zeria Investigative Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Zeria Investigative sites
City
Bratislava
Country
Slovakia
Facility Name
Zeria Investigative sites
City
Kosice
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Malacky
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Martin
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Nitra
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Presov
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Trnava
Country
Slovakia
Facility Name
Zeria Investigative Site
City
Gothenburg
Country
Sweden
Facility Name
Zeria Investigative Sites
City
Stockholm
Country
Sweden
Facility Name
Zeria Investigative Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Zeria Investigative Site
City
Kyiv
Country
Ukraine
Facility Name
Zeria Investigative Site
City
Vinnytsya
Country
Ukraine
Facility Name
Zeria Investigative site
City
Barnstaple
Country
United Kingdom
Facility Name
Zeria Investigative site
City
Bath
Country
United Kingdom
Facility Name
Zeria Investigative Site
City
Leamington Spa
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29315999
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.
Results Reference
derived

Learn more about this trial

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

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