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CYP2C19 Genetic Polymorphism on the Accuracy of Proton-Pump Inhibitor Testing

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ClinicalTrials.gov Identifier: NCT00354757
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Background/Aim: To evaluate the optimal dosage of rabeprazole for proton-pump inhibitor (PPI) testing of gastroesophageal reflux disease (GERD) and to test the influence of cytochrome P (CYP) 2C19 polymorphism in a population with a high prevalence of people who poorly metabolize PPIs.

Patients and Methods: In this randomized, open-label trial, patients with symptoms suggestive of GERD were randomized to receive a two-week test with 20-mg or 40-mg rabeprazole after diagnostic endoscopy. Symptom response was assessed with a four-grade daily record; in addition, DNA from peripheral blood leukocytes was genotyped for CYP2C19 polymorphism with polymerase chain reaction-restrict fragment length polymorphism (PCR-RFLP) technique.


Condition or disease Intervention/treatment Phase
GERD Drug: rabeprazole Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Influence of CYP2C19 Genetic Polymorphism and Dosage of Rabeprazole on the Accuracy of Proton-Pump Inhibitor Testing in Chinese Patients With Gastroesophageal Reflux Disease
Study Start Date : June 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2 arms
PPI 1
Drug: rabeprazole
Active Comparator: PPI
PPI 2
Drug: rabeprazole



Primary Outcome Measures :
  1. Symptom response with a four-grade daily record. [ Time Frame: 2 weeks ]
    GERD symptom assessment


Secondary Outcome Measures :
  1. CYP2C19 polymorphism [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A consecutive series of patients with symptoms suggestive of GERD were enrolled from the Gastroenterology outpatient clinic in our institution. The typical GERD symptom was defined as heartburn and/or acid regurgitation of at least three episodes per week for a minimum of three months.

Exclusion Criteria:

  • Patients who received concurrent PPI treatment, had a medical contraindication to rabeprazole therapy, reported a history of peptic ulcer disease or gastrointestinal surgery, peptic ulcer disease or malignancy proven by endoscopy, the presence of alarm features (e.g., dysphagia, weight loss, bleeding, abdominal mass, and/or anemia), or who were unwilling or unable to provide informed consent were excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354757


Locations
Taiwan
National Taiwan Univeristy Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ming-Shiang Wu, PHD National Taiwan University Hospital

Publications of Results:
Abstract, DDW, 2006, Los Angeles

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00354757     History of Changes
Other Study ID Numbers: 940711
940711
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
gastroesophageal reflux disease, proton-pump inhibitor test

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action