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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:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00681005
First received: May 15, 2008
Last updated: May 19, 2008
Last verified: April 2008
History of Changes
  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:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 Drug: rabeprazole
20 mg bid for 14 days
Other Name: Pariet
Active Comparator: pantoprazole 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
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: Ming-Shiang Wu,Professor, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00681005     History of Changes
Other Study ID Numbers: 950204
Study First Received: May 15, 2008
Last Updated: May 19, 2008
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
Proton Pump Inhibitors
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013