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

Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973790
• Other study ID #: Z338-01
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2013
• Last updated: June 27, 2017
• Start date: March 2014
• Est. completion date: April 2017

Study information

• Verified date: January 2017
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Z-338
100mg TID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Latvia,  Lithuania,  Romania,  Russian Federation,  Slovakia,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General safety endpoints	Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination	up to 58 weeks
Secondary	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