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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973790
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Z-338 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Z-338
100mg TID
Drug: Z-338
100mg TID
Other Name: Acotiamide




Primary Outcome Measures :
  1. General safety endpoints [ Time Frame: up to 58 weeks ]
    Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973790


  Show 36 Study Locations
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
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Principal Investigator: Jan Tack, MD, PhD University of Leuven, University Hospital Gasthuisberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT01973790     History of Changes
Other Study ID Numbers: Z338-01
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: January 2017

Keywords provided by Zeria Pharmaceutical:
Z-338
Functional Dyspepsia
Postprandial Distress Syndrome

Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Z 338
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Gastrointestinal Agents