Status and phase
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About
The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to:
Full description
This is a muti-national study, in subjects with functional dyspepsia. The study will screen approximately 700 subjects and include 564 subjects (282 subjects in both arms Test and Active control arm) and the treatment will be given as follows.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adult male and/or non-pregnant non-lactating female subjects aged above 18 years.
Subjects provided written informed consent and are willing to participate in the study.
Subjects with functional (non-ulcer) dyspepsia according to Rome IV criteria including postprandial distress syndrome (PDS) and with or without EPS (epigastric pain syndrome) with one or more of the following:
No evidence of organic, systemic, metabolic or structural disease likely to explain symptoms - Subjects who have to undergone physical examination and lab tests (including white-cell and red-cell counts, measurement of fasting blood sugar and liver-function tests), abdominal ultrasonography, and upper GI endoscopy* in order to rule out structural cause for symptoms of FD.
*history of upper GI endoscopy within 6 months prior to enrolment or at screening.
Baseline severity of at least moderate symptoms on LDQ (total score ≥ 9) at screening.
H. pylori negative documented test report within 3 months prior to enrolment or during screening.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
564 participants in 2 patient groups
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Central trial contact
Suntje Sander
Data sourced from clinicaltrials.gov
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