A Comparative Study of Proton-Pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD
Intervention: rabeprazole (Drug); pantoprazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Ming-Shiang Wu, MD, PhD, Study Director, Affiliation: National Taiwan University Hospital
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.
Clinical Details
Official title: A Comparative Study of Proton-Pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes
Study design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: at least 50% reduction of symptoms
Detailed description:
As described above
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Consecutive patients with symptoms suggesting GERD will be enrolled from
gastroenterology outpatient clinics in our academic institute. The typical GERD
symptom was defined as heartburn and/or regurgitation at least 3 episodes per week in
recent 3 months.
Exclusion Criteria:
- Those who were under maintenance PPI treatment, have a medical contraindication to PPI
therapy, report a history of peptic ulcer disease or gastrointestinal surgery,
malignancy proven by endoscopy, or unwilling or unable to provide informed consent.
Locations and Contacts
Additional Information
Starting date: April 2006
Ending date: January 2008
Last updated: May 19, 2008
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