To assess the effect of Iberogast on heartburn, the incidence of reflux episodes and oesophageal sensitivity in patients with functional dyspepsia.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the GORD symptom score improvement based on the RDQ
Questionnaire score.
Secondary outcome
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 Short Form Nepean Dyspepsia Index (SF-NDI)
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)
Oesophageal motility
LOS-pressure
Oesophageal contractility
Background summary
Iberogast (STW5) is a multitarget herbal preparation which has been shown to
effectively reduce symptoms in patients with functional dyspepsia. Many
patients have, in addition to functional dyspepsia, heartburn complaints. Thus
far, the mechanism of action of Iberogast in heartburn reduction is unknown. It
has been demonstrated that the incidence of gastro-oesophageal reflux episodes
is influenced by gastric motility and emptying. Since Iberogast affects
proximal gastric motility, Iberogast could, in theory, result in a reduced
incidence of reflux episodes in patients with dyspepsia. It is also possible
that Iberogast could reduce the sensitivity of the oesophagus and stomach, and
thus reduce perception of the refluxate. Given that the effect of proton pump
inhibitors in dyspepsia with heartburn is small and the alternative treatment
options are limited, a positive result could have a major effect on the
treatment of heartburn in this patient population.
Study objective
To assess the effect of Iberogast on heartburn, the incidence of reflux
episodes and oesophageal sensitivity in patients with functional dyspepsia.
Study design
A prospective phase III study with a double blind placebo-controlled,
randomized cross-over design.
Intervention
All patients will receive in one period either a placebo or Iberogast (20 drops
three times daily) for at least 4 weeks, followed by a second period in which
they will receive the other study medication (placebo if they received
Iberogast during the first period and Iberogast if they received placebo during
the first period).
Study burden and risks
Discomfort associated with the oesophageal sensitivity test and side effects of
Iberogast.
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003739-40-NL |
| CCMO | NL59153.018.16 |