DyspepsiaPhase 3NCT01973790
Phase III, Long-term, Open-label Safety Study of Z-338
A Phase 3 study testing Z-338 in people with Dyspepsia, run by Zeria Pharmaceutical at 36 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Z-338
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 36 sitesin 10 countries
- Study dates
- Mar 2014to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
Slovakia7 sites
Zeria Investigative sites
Bratislava
Zeria Investigative sites
Košice
Zeria Investigative Site
Malacky
Zeria Investigative Site
Martin
Zeria Investigative Site
Nitra
Zeria Investigative Site
Prešov
Zeria Investigative Site
Trnava
Romania6 sites
Zeria Investigative Site
Brasov
Zeria Investigative Sites
Bucharest
Zeria Investigative Sites
Cluj-Napoca
Zeria Investigative Site
Sibiu
Zeria Investigative Site
Târgu Mureş
Zeria Investigative Sites
Timișoara
Lithuania4 sites
Zeria Investigative Site
Alytus
Zeria Investigative Sites
Kaunas
Zeria Investigative Site
Klaipėda
Zeria Investigative Site
Vilnius
Russia4 sites
Zeria Investigative Site
Kazan'
Zeria Investigative Site
Ryazan
Zeria Investigative Site
Saratov
Zeria Investigative Site
Yaroslavl
Bulgaria3 sites
Zeria Investigative Site
Plovdiv
Zeria Investigative Sites
Sofia
Zeria Investigative site
Varna
Latvia3 sites
Zeria Invetigative Site
Liepāja
Zeria Investivgative SIte
Limbaži
Zeria Investigative Sites
Riga
Ukraine3 sites
Zeria Investigative Site
Dnipropetrovsk
Zeria Investigative Site
Kyiv
Zeria Investigative Site
Vinnytsia
United Kingdom3 sites
Zeria Investigative site
Barnstaple
Zeria Investigative site
Bath
Zeria Investigative Site
Royal Leamington Spa
Sweden2 sites
Zeria Investigative Site
Gothenburg
Zeria Investigative Sites
Stockholm
About this study
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
The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.
Read the 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.
- Conditions
- Dyspepsia
- Being tested
- Z-338
- Keywords
- Z-338, Functional Dyspepsia, Postprandial Distress Syndrome
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-338Drug
Also called Acotiamide
100mg TID
| Study group | Role | What they receive |
|---|---|---|
| Z-338 | Experimental | 100mg TID Receives: Drug: Z-338 |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety endpoints
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
Measured: up to 58 weeks
Secondary outcomes (1)
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.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, PhD, Principal investigator, University of Leuven, University Hospital Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973790
- Sponsor's protocol ID
- Z338-01
- Status last verified
- Jan 2017
- First submitted
- 26 Oct 2013
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29315999
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01973790
- Acronym / sponsor ID
- Z338-01
- Conditions
- Dyspepsia
- Keywords
- Z-338, Functional Dyspepsia, Postprandial Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Z-338 | Experimental | Drug: Z-338100mg TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-338Also: Acotiamide100mg TID | Drug | Z-338 |
Primary outcome
General safety endpoints
Time frame: up to 58 weeks
Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
1 secondary outcome
To explore the efficacy
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 29315999Tack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD, PhD principal investigator
University of Leuven, University Hospital Gasthuisberg
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Z-338 in people with Dyspepsia, run by Zeria Pharmaceutical at 36 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Slovakia, Romania, Lithuania, Russia, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General safety endpoints (time frame: up to 58 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.