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

NCT00354757 | Completed Phase 4

• 1 other identifier: 940711
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD

Keywords

gastroesophageal reflux disease, proton-pump inhibitor test

Outcome Measures

Primary Outcomes (1)

• Symptom response with a four-grade daily record.

  GERD symptom assessment

  2 weeks

Secondary Outcomes (1)

• CYP2C19 polymorphism

  2 weeks

Study Arms (2)

2 arms

ACTIVE COMPARATOR

PPI 1

Drug: rabeprazole

PPI

ACTIVE COMPARATOR

PPI 2

Drug: rabeprazole

Interventions

rabeprazole DRUG

2 arms; PPI

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taipei, 100, Taiwan

Location

Related Publications (1)

• Abstract, DDW, 2006, Los Angeles

  RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ming-Shiang Wu, PHD

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: June 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

TW (1)