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The effect of Iberogast on heartburn in patients with functional dyspepsia

Phase 3
Completed
Conditions
Heartburn
pyrosis
10017977
Registration Number
NL-OMON49070
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
18
Inclusion Criteria

* Age above 18
* A history of dyspepsia (according to the Rome IV criteria) with heartburn
* Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if deemed necessary by the physician

Exclusion Criteria

* Surgery of the GI tract other than appendectomy or cholecystectomy
* Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. proton pump inhibitors, H2-blockers, antidepressants, prokinetics)
* Proton pump inhibitors must be stopped at least 7 days before start of the study
* Known Barrett*s oesophagus
* History of GI cancer
* Known allergy to one of the ingredients of Iberogast
* Known diabetes
* Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
* Pregnancy (women will be asked if they are pregnant)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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