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

Matthias Schwab

Status and phase: Terminated; Phase 4

Conditions: Gastroesophageal Reflux

Treatments: Drug: omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00537732

2006-004650-24 (EudraCT Number)

IKP-219

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

control group

Active Comparator group

Description:

3 tablets, only 20 mg omeprazole, genotype independent

Treatment:

Drug: omeprazole

Drug: omeprazole

intervention group

Active Comparator group

Description:

20 vs. 60 mg daily, genotype dependent

Treatment:

Drug: omeprazole

Drug: omeprazole