Gastroesophageal Reflux
Conditions
Keywords
gastro-oesophageal reflux disease
Brief summary
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.
Interventions
DRUGomeprazole
20 mg daily
Sponsors
Matthias Schwab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory * Range of Age: 20-70 * BMI: 20-30
Exclusion criteria
* Patients who are allergic to proton-pump inhibitors or show incompatibility * Patients who have lactase deficiency * Patients who have severe chronic disease * Patients who participated in another study during the last three months * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole | 4 weeks |
Countries
Germany
Outcome results
None listed