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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00681005
First received: May 15, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
GERD
Drug: rabeprazole
Drug: pantoprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • at least 50% reduction of symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rabeprazole
Rabeprazole 1 # qd
Drug: rabeprazole
20 mg bid for 14 days
Other Name: Pariet
Active Comparator: pantoprazole
Pantoprazole 1# qd
Drug: pantoprazole
pantoprazole 40 mg bid
Other Name: Pantoloc

Detailed Description:

As described above

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00681005

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ming-Shiang Wu, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00681005     History of Changes
Other Study ID Numbers: 950204
Study First Received: May 15, 2008
Last Updated: December 9, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
PPI test
gastroesophageal reflux disease
CYP2C19
rabeprazole
pantoprazole

Additional relevant MeSH terms:
Pantoprazole
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014