Stereoselective pharmacokinetics and CYP2C19-genotyping as outcome predictors of an omeprazole therapy in patients with GERD -- a pilot study (phase IV-study)
- Conditions
- The presented study has to evaluate whether an optimized individual dosage of proton pump inhibitors, adjusted to CYP2C19 genotype, leads to a better pharmakodynamic effect (pH metric acid suppression). This question shall be examined within a duration of 14 days of therapy.
- Registration Number
- EUCTR2006-002346-11-DE
- Lead Sponsor
- Medical Faculty, Otto-von-Guericke University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Patients:
- male and female
- Caucasians
- 20-70 years old
- 50-85 kg body weight
- patients with GERD, grade A and B Los Angeles classification
- otherwise inconspicuous physical examination and clinical laboratory
parameters
- signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- therapy with proton pump inhibitors
- actual H. pylori infection, or H. pylori infection treated in the last 3 months
- known allergies against proton pump inhibitors and/or H2-receptorantagonists
- continuous intake of systemic or local acting drugs with interaction potential related
to the study drug (CYP 2C19 or CYP 3A4) (Anlage K) in the last 4 weeks prior the
study, exception is permitted for single dose administration until 48 hours prior the
study
- alcohol consumption (more than 40 g/day, 2 bottles beer), nicotine consumption
(more than 3 cigarettes/day)
- participation in other clinical studies within the last 3 months
- donation of blood within the last 8 weeks prior the study
- serious diseases of the patient (e.g. diseases of central nervous system, psychiatric
diseases, chronic or acute infections) if they are contrary to the inclusion criteria
- pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method