Dyspepsia (according to the Rome III criteria) with heartburn. Upper gastro-intestinal causes of the complaints excluded via gastroscopy
Conditions
Interventions
Trade Name: Iberogast
Pharmaceutical Form: Oral liquid
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Sponsors
AMC Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Iberogast on heartburn, the number of reflux episodes and sensitivity in patients with dyspepsia.;Secondary Objective: Not applicable;Primary end point(s): Gastro-oesophageal reflux disease symptom score improvement based on RDQ Questionnaire score;Timepoint(s) of evaluation of this end point: Week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of gastro-oesophageal reflux episodes during the 24-hr study (both mixed/liquid reflux episodes and both acidic and non-acidic episodes) Proportion of acid and non-acid reflux episodes Total acid exposure time during 24-hour pH-impedance studies Quality of life (using the Quality of life in Reflux and Dyspepsia QoLRaD Questionnaire) Oesophageal sensitivity to acid perfusion Time to symptoms during oesophageal acid exposure Time to pain during oesophageal acid exposure (if present) Symptom severity during oesophageal acid exposure (VAS);Timepoint(s) of evaluation of this end point: Week 4 and week 8 | — |
Countries
Netherlands
Contacts
Public Contactmotiliteitscentrum
AMC Amsterdam
Outcome results
None listed