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: 9.1 Level: LLT Classification code 10038263 Term: Reflux oesophagitis
Conditions
Interventions
Trade Name: Nexium mups 20 mg
Product Name: Esomeprazol
Product Code: Esomeprazol
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: esomeprazole
CAS Number: 217087097
Other descriptive name
Sponsors
Medical Faculty, Otto-von-Guericke University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Genotyping: Determination of genetic polymorphism for alleles CYP2C19*1, CYP2C19*2, CYP2C19*3 Pharmacokinetics: Stereoisomeric analysis of (S-)omeprazole and its metabolites, calculation of: 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 Pharmacodynamics: 24-hours pH-metrics of stomach;Secondary Objective: ;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed