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 (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00681005
First received: May 15, 2008
Last updated: December 9, 2013
Last verified: December 2013

May 15, 2008
December 9, 2013
April 2006
January 2008   (final data collection date for primary outcome measure)
at least 50% reduction of symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681005 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes
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.

As described above

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
GERD
  • Drug: rabeprazole
    20 mg bid for 14 days
    Other Name: Pariet
  • Drug: pantoprazole
    pantoprazole 40 mg bid
    Other Name: Pantoloc
  • Active Comparator: Rabeprazole
    Rabeprazole 1 # qd
    Intervention: Drug: rabeprazole
  • Active Comparator: pantoprazole
    Pantoprazole 1# qd
    Intervention: Drug: pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
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NCT00681005
950204
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Director: Ming-Shiang Wu, MD, PhD National Taiwan University Hospital
National Taiwan University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP