Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
- Registration Number
- NCT00537732
- Lead Sponsor
- Matthias Schwab
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group omeprazole 3 tablets, only 20 mg omeprazole, genotype independent intervention group omeprazole 20 vs. 60 mg daily, genotype dependent
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole 4 weeks
Trial Locations
- Locations (1)
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
🇩🇪Stuttgart, Baden-Württemberg, Germany