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A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes

NCT00681005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2013-12-11

No results posted yet for this study

Summary

Backgrounds \& Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed that a higher prevalence of poor metabolizers in Chinese population might affect the diagnostic accuracy of a PPI test.

Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole 80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.

Conditions

  • GERD

Interventions

DRUG

rabeprazole

20 mg bid for 14 days

DRUG

pantoprazole

pantoprazole 40 mg bid

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Shiang Wu, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

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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 NCT00681005 on ClinicalTrials.gov