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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control group

3 tablets, only 20 mg omeprazole, genotype independent

Group Type ACTIVE_COMPARATOR

omeprazole

Intervention Type DRUG

20 mg daily

intervention group

20 vs. 60 mg daily, genotype dependent

Group Type ACTIVE_COMPARATOR

omeprazole

Intervention Type DRUG

20 vs. 60 mg daily, genotype dependent

Interventions

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omeprazole

20 mg daily

Intervention Type DRUG

omeprazole

20 vs. 60 mg daily, genotype dependent

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No