Stereoselective pharmacokinetics and CYP2C19-genotyping as outcome predictors of an esomeprazole 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 pharmacokinetic effect (pH metric acid suppression). This question shall be examined within a duration of 14 days of therapy.MedDRA version: 9.1Level: LLTClassification code 10038263Term: Reflux oesophagitis
- Registration Number
- EUCTR2008-001302-16-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 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 (CYP2C19 or CYP3A4) (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 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 Main Objective: Genotyping:<br>Determination of genetic polymorphism for alleles CYP2C19*1, CYP2C19*2, CYP2C19*3<br>Pharmacokinetics:<br>Stereoisomeric analysis of (S-)omeprazole and its metabolites,<br>calculation of:<br>terminal half life [t½], area under the curve [AUC] from 0 to 12 h (trapezoid rule, non-compartimental distribution), metabolic ratios (MQ), AUC_5-OH-Esome/AUC_Esome, AUC_Ome-sulfon/AUC_5-OH-Esome, AUC_Ome-sulfon/AUC_Esome<br>Pharmacodynamics:<br>24-hours pH-metrics of stomach;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method