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:
Zeria Pharmaceutical
Information provided by (Responsible Party):
Zeria Pharmaceutical
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 (Clinical Trial) |
| Actual Enrollment : | 207 participants |
| Allocation: | N/A |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Z-338
100mg TID
|
Drug: Z-338
100mg TID
Other Name: Acotiamide |
Primary Outcome Measures :
- General safety endpoints [ Time Frame: up to 58 weeks ]Adverse Events, 12-lead ECGs, Laboratory variables, Vital signs, Physical examination
Secondary Outcome Measures :
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Locations
Show 36 study locations
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
| Principal Investigator: | Jan Tack, MD, PhD | University of Leuven, University Hospital Gasthuisberg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Zeria Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT01973790 |
| 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:
|
Dyspepsia Signs and Symptoms, Digestive Z 338 Cholinesterase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Gastrointestinal Agents |