MedTrace Logo

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

NCT00537732 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

omeprazole

20 mg daily

DRUG

omeprazole

20 vs. 60 mg daily, genotype dependent

Sponsors & Collaborators

  • Matthias Schwab

    lead OTHER

Principal Investigators

  • Matthias Schwab, Prof, MD · Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537732 on ClinicalTrials.gov