Phase III, Long-term, Open-label Safety Study of Z-338 | NCT01973790

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Nov 2016Actual

Completion Date

Apr 2017Actual

First Submitted Date

Oct 26, 2013

First Submission Date that Met QC Criteria

Oct 31, 2013

First Posted Date

Nov 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2017

Last Update Posted Date

Jun 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Label	Type	Description	Intervention Names
Z-338	Experimental	100mg TID	Drug: Z-338

Name	Type	Description	Arm Group Labels	Other Names
Z-338	Drug	100mg TID	Z-338	Acotiamide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.	up to 52 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jan Tack, MD, PhD	University of Leuven, University Hospital Gasthuisberg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Zeria Investigative site		Leuven			Belgium
Zeria Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29315999	Derived	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.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms