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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• A consecutive series of patients with symptoms suggestive of GERD were enrolled from the Gastroenterology outpatient clinic in our institution. The typical GERD symptom was defined as heartburn and/or acid regurgitation of at least three episodes per week for a minimum of three months.

Exclusion Criteria:

• Patients who received concurrent PPI treatment, had a medical contraindication to rabeprazole therapy, reported a history of peptic ulcer disease or gastrointestinal surgery, peptic ulcer disease or malignancy proven by endoscopy, the presence of alarm features (e.g., dysphagia, weight loss, bleeding, abdominal mass, and/or anemia), or who were unwilling or unable to provide informed consent were excluded from the study.