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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00681005
Enrollment
178
Registered
2008-05-20
Start date
2006-04-30
Completion date
2008-01-31
Last updated
2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

PPI test, gastroesophageal reflux disease, CYP2C19, rabeprazole, pantoprazole

Brief 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.

Detailed description

As described above

Interventions

DRUGrabeprazole

20 mg bid for 14 days

DRUGpantoprazole

pantoprazole 40 mg bid

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
at least 50% reduction of symptoms2 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026