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NCT00681005 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681005
Other study ID # 950204
Secondary ID
Status Completed
Phase N/A
First received May 15, 2008
Last updated December 9, 2013
Start date April 2006
Est. completion date January 2008

Study information
Verified date December 2013
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

As described above

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rabeprazole
20 mg bid for 14 days
• pantoprazole
pantoprazole 40 mg bid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary at least 50% reduction of symptoms 2 weeks
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