drugset / Trial / NCT00354757

CYP2C19 Genetic Polymorphism on the Accuracy of Proton-Pump Inhibitor Testing

NCT00354757

Phase 4 Completed 200 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelDiagnostic

Summary

Background/Aim: To evaluate the optimal dosage of rabeprazole for proton-pump inhibitor (PPI) testing of gastroesophageal reflux disease (GERD) and to test the influence of cytochrome P (CYP) 2C19 polymorphism in a population with a high prevalence of people who poorly metabolize PPIs. Patients and Methods: In this randomized, open-label trial, patients with symptoms suggestive of GERD were randomized to receive a two-week test with 20-mg or 40-mg rabeprazole after diagnostic endoscopy. Symptom response was assessed with a four-grade daily record; in addition, DNA from peripheral blood leukocytes was genotyped for CYP2C19 polymorphism with polymerase chain reaction-restrict fragment length polymorphism (PCR-RFLP) technique.

Timeline

Start
2005-06
Primary completion
2008-06
Completion
2008-12

Publications

  • Results Abstract, DDW, 2006, Los Angeles

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rabeprazole Small molecule 20 mg Oral
Comparator Rabeprazole Small molecule 40 mg Oral