Official Title: “A Comparative Study of Proton-Pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2008

As described above

Intervention(s) in this Clinical Trial

• Drug: rabeprazole
  • 20 mg bid for 14 days
• Drug: pantoprazole
  • pantoprazole 40 mg bid

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Rabeprazole
• Active Comparator: pantoprazole

Primary Measures

• at least 50% reduction of symptoms
  • Time Frame: 2 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Taiwan University Hospital

Overall Clinical Trial Officials and Contacts

Ming-Shiang Wu, MD, PhD Study Director National Taiwan University Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00681005

Study ID Number: 950204

ClinicalTrials.gov Identifier: NCT00681005

Health Authority: Taiwan: Department of Health