Trial | NCT00537732  Report issue

Official Title

Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    omeprazole ...

  • Study Participants

    68
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.
Study Started
Apr 30
2007
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Feb 25
2014
Estimate

Drug omeprazole

20 mg daily

Drug omeprazole

20 vs. 60 mg daily, genotype dependent

control group Active Comparator

3 tablets, only 20 mg omeprazole, genotype independent

intervention group Active Comparator

20 vs. 60 mg daily, genotype dependent

Criteria 

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
No Results Posted