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

NCT ID: NCT00681005

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-01-31

Brief Summary

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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

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As described above

Conditions

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GERD

Keywords

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PPI test gastroesophageal reflux disease CYP2C19 rabeprazole pantoprazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rabeprazole

Rabeprazole 1 # qd

Group Type ACTIVE_COMPARATOR

rabeprazole

Intervention Type DRUG

20 mg bid for 14 days

pantoprazole

Pantoprazole 1# qd

Group Type ACTIVE_COMPARATOR

pantoprazole

Intervention Type DRUG

pantoprazole 40 mg bid

Interventions

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rabeprazole

20 mg bid for 14 days

Intervention Type DRUG

pantoprazole

pantoprazole 40 mg bid

Intervention Type DRUG

Other Intervention Names

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Pariet Pantoloc

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Shiang Wu, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Other Identifiers

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950204

Identifier Type: -

Identifier Source: org_study_id