The effect of Iberogast on heartburn in patients with indigestion.

Phase 1

Active, not recruiting

• Conditions: Dyspepsia (according to the Rome III criteria) with heartburn.Upper gastro-intestinal causes of the complaints excluded via gastroscopy; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003739-40-NL
• Lead Sponsor: AMC Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-06
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age above 18
• A history of dyspepsia (according to the Rome III criteria) with heartburn
• Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if found to be necessary by the physician
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, tricyclic antidepressants …)
• Proton pump inhibitors cannot be stopped for 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 clinical trial of medicinal product
• Study Design: Not specified