Heartburn pyrosis
Conditions
Interventions
Patients will receive the first period either a placebo or Ziverel four times
daily for 14 days, followed by a second period in which they will receive the
other study medication. There will be a wa
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age above 18 years - Symptoms of heartburn and/or acid regurgitation under PPI treatment for at least 3 months. - Use of proton pump inhibitors at a standard two times daily dose for at least 4 weeks prior to inclusion, same dosage should be maintained during the entire study period.
Exclusion criteria
Exclusion criteria: - Previous gastric or major gastrointestinal surgery other than appendectomy or cholecystectomy. - Use of any other medication than proton pump inhibitors with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. H2-blockers, antidepressants, prokinetics, antacids) - Known Barrett*s esophagus - History of gastrointestinal cancer - Known allergy to one of the ingredients of Ziverel - Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) - Pregnant, lactating or fertile women (without contraception)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the perfusion sensitivity score (acid perfusion test). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are (1) symptom score improvement based on the RDQ Questionnaire score, and (2) esophageal barrier function measured with Ussing chamber experiments and electrical tissue impedance spectroscopy during endoscopy. | — |
Countries
Netherlands
Outcome results
None listed