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

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, October 2008

First Received: July 18, 2006 Last Updated: October 23, 2008 History of Changes

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00354757

Purpose

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	Intervention	Phase
GERD	Drug: rabeprazole	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: GERD

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Symptom responsewith a four-grade daily record.

Secondary Outcome Measures:

CYP2C19 polymorphism

Estimated Enrollment:	200
Study Start Date:	June 2005
Estimated Study Completion Date:	February 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354757

Contacts

Contact: yi-chia lee, MD

0968661689

yclee@ha.mc.ntu.edu.tw

Locations

Taiwan
National Taiwan Univeristy Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Yi-Chia Lee, MD 0968661689 yclee@ha.mc.ntu.edu.tw
Principal Investigator: yi-chia Lee, MD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Director:

Ming-Shiang Wu, PHD

National Taiwan University Hospital

More Information

No publications provided

Study ID Numbers:	940711, 940711
Study First Received:	July 18, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00354757 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

gastroesophageal reflux disease, proton-pump inhibitor test

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010