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

June 27, 2017 updated by: Zeria Pharmaceutical

A Phase III, Multicentre, Single-arm, Open-label Study to Evaluate the Long-term Safety of Z-338 in Subjects With Functional Dyspepsia

The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Zeria Investigative Site
  • Bulgaria
      • Plovdiv, Bulgaria
        • Zeria Investigative Site
      • Sofia, Bulgaria
        • Zeria Investigative Sites
      • Varna, Bulgaria
        • Zeria Investigative Site
  • Latvia
      • Liepaja, Latvia
        • Zeria Invetigative Site
      • Limbazi, Latvia
        • Zeria Investivgative SIte
      • Riga, Latvia
        • Zeria Investigative Sites
  • Lithuania
      • Alytus, Lithuania
        • Zeria Investigative Site
      • Kaunas, Lithuania
        • Zeria Investigative Sites
      • Klaipeda, Lithuania
        • Zeria Investigative Site
      • Vilnius, Lithuania
        • Zeria Investigative Site
  • Romania
      • Brasov, Romania
        • Zeria Investigative Site
      • Bucharest, Romania
        • Zeria Investigative Sites
      • Cluj-Napoca, Romania
        • Zeria Investigative Sites
      • Sibiu, Romania
        • Zeria Investigative Site
      • Timisoara, Romania
        • Zeria Investigative Sites
      • Tirgu Mures, Romania
        • Zeria Investigative Site
  • Russian Federation
      • Kazan, Russian Federation
        • Zeria Investigative Site
      • Ryazan, Russian Federation
        • Zeria Investigative Site
      • Saratov, Russian Federation
        • Zeria Investigative Site
      • Yaroslavl, Russian Federation
        • Zeria Investigative Site
  • Slovakia
      • Bratislava, Slovakia
        • Zeria Investigative Sites
      • Kosice, Slovakia
        • Zeria Investigative Sites
      • Malacky, Slovakia
        • Zeria Investigative Site
      • Martin, Slovakia
        • Zeria Investigative Site
      • Nitra, Slovakia
        • Zeria Investigative Site
      • Presov, Slovakia
        • Zeria Investigative Site
      • Trnava, Slovakia
        • Zeria Investigative Site
  • Sweden
      • Gothenburg, Sweden
        • Zeria Investigative Site
      • Stockholm, Sweden
        • Zeria Investigative Sites
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Zeria Investigative Site
      • Kyiv, Ukraine
        • Zeria Investigative Site
      • Vinnytsya, Ukraine
        • Zeria Investigative Site
  • United Kingdom
      • Barnstaple, United Kingdom
        • Zeria Investigative Site
      • Bath, United Kingdom
        • Zeria Investigative Site
      • Leamington Spa, United Kingdom
        • Zeria Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Z-338
100mg TID
Drug: Z-338
100mg TID
Other Names:
  • Acotiamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General safety endpoints
Time Frame: up to 58 weeks
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
up to 58 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Investigators

  • Principal Investigator: Jan Tack, MD, PhD, University of Leuven, University Hospital Gasthuisberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (ESTIMATE)

November 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z338-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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