Relation of Metabolic Rate of Omeprazole and Eradication of Helicobacter Pylori Infection

March 1, 2009 updated by: National Taiwan University Hospital

Relation of Metabolic Rate of Omeprazole and Eradication of Helicobacter Pylori Infection - A Combination of Clinical and Pharmacogenetic Study

The aims of this study are (1) to evaluate the prevalence rate of PM of CYP2C19 in our country; (2) to evaluate the efficacy of dual therapy with different dose of omeprazole and amoxicillin; (3) to judge the relationship of genotype of CYP2C19 and the eradication rate of dual therapy in the peptic ulcer patients; (4) to try to find out a predictor of success of dual therapy and an optimal dose of dual therapy as first-line and rescue anti-Helicobacter pylori regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anti-H. pylori therapy is now recommended in patients with peptic ulcer disease associated with bacterial infection. Dual therapy containing one PPI and amoxicillin has been suggested to be a better treatment than classical triple therapy containing bismuth, metronidazole, and tetracycline for H. pylori eradication due to its better compliance and fewer side effects. However, the variation in the eradication rate among different studies has limited its clinical application. Nonetheless, the amoxicillin-based dual therapy, with very rare prevalence of primary and secondary antibiotic resistance, has the potential to be an optimal first-line and rescue anti-Helicobacter pylori regimen if the confounding factors that cause the labile treatment outcome can be clarified. Cytochrome P450 2C19(CYP2C19), the enzyme that metabolizes omeprazole, was found to have genetic polymorphism in its enzyme activity. The percentage of poor metabolizer(PM) of CYP2C19 was much higher in Oriental(18~23%) comparing to Caucasian(3~5%).

The aims of this study is to try to find out a predictor of success of dual therapy and an optimal dose of dual therapy as first-line and rescue anti-Helicobacter pylori regimen. About 130 patients with Hp positive duodenal ulcer will be enrolled and allocated randomly into one of four treatment groups:Group A：omeprazole 20mg bid 2wk + amoxicillin 500mg qid 2wk; Group B：omeprazole 20mg bid 2wk + amoxicillin 250mg qid 2wk; Group C：omeprazole 20mg qd 2wk + amoxicillin 500mg qid 2wk; Group D：omeprazole 20mg qd 2wk + amoxicillin 250mg qid 2wk. All patients will receive endoscopic exam with biopsy again within 1~2 months after the end of treatment. The status of H. pylori infection was examined by endoscopy or the 13C-urea breath test (if the patients refused the second endoscopy). Biopsy from the antrum and body will be taken for the culture, histology and CLO test. Twenty-four hours intragastric pH measurements will be performed on 6 randomly selective patients of each group when these patients complete the first week course of treatment. PCR-RFLP method will be used to detect genotype of CYP2C19 polymorphism using the genomic DNA extracted from the whole blood in all 130 treated patients. The genotyping results will be correlated with the H. pylori eradication rate and intragastric pH value.

The equivalence of demographic information among various treatment groups or genotypes will be revealed by chi-square independence test, t-test, one-way ANOVA, or Kruskal-Wallis test. The above statistical methods as well as Mann-Whitney test will be also used to analyze clinical outcome. Confidence intervals for eradication rates will be computed by plus-four method. Multiple logistic regression will be used to explore the predictor of the eradication outcome. Multiple regression will be used to explore the predictor of the intragastric acidity. A p-value less than 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10043
        • Department of Internal Medicine, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female dyspeptic patients with H. pylori-positive duodenal ulcer.

Exclusion Criteria:

  • Pregnant or nursing woman
  • Serious concomitant illness
  • Malignant tumor of any kind
  • Serious bleeding during the course of this ulcer
  • Previous gastric surgery
  • Taking bismuth compounds, proton pump inhibitors, antibiotic or non-steroid anti-inflammatory drugs for at least one month prior to pretreatment endoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 omeprazole plus amoxicillin
omeprazole 20mg bid 2wk + amoxicillin 500mg qid 2wk
Drug: omeprazole plus amoxicillin
Active Comparator: 2 omeprazole plus amoxicillin
omeprazole 20mg bid 2wk + amoxicillin 250mg qid 2wk
Drug: omeprazole plus amoxicillin
Active Comparator: 3 omeprazole plus amoxicillin
omeprazole 20mg qd 2wk + amoxicillin 500mg qid 2wk
Drug: omeprazole plus amoxicillin
Active Comparator: 4 omeprazole plus amoxicillin
omeprazole 20mg qd 2wk + amoxicillin 250mg qid 2wk
Drug: omeprazole plus amoxicillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Helicobacter pylori eradication rate and intragastric pH value

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Jyh-Chin Yang, M.D., Department of Internal Medicine, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1996

Primary Completion (Actual)

December 1, 1997

Study Completion (Actual)

February 1, 1998

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

March 1, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 3, 2009

Last Update Submitted That Met QC Criteria

March 1, 2009

Last Verified

July 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC86-2314-B002-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helicobacter Pylori Infection

Clinical Trials on omeprazole plus amoxicillin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe