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

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National Taiwan University

Status

Completed

Conditions

GERD

Treatments

Drug: pantoprazole
Drug: rabeprazole

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

As described above

Enrollment

178 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

178 participants in 2 patient groups

Rabeprazole
Active Comparator group
Description:
Rabeprazole 1 # qd
Treatment:
Drug: rabeprazole
pantoprazole
Active Comparator group
Description:
Pantoprazole 1# qd
Treatment:
Drug: pantoprazole

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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