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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854451
First received: February 6, 2009
Last updated: March 1, 2009
Last verified: July 1996
  Purpose

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.


Condition Intervention Phase
Duodenal Ulcer
Helicobacter Pylori Infection
Drug: omeprazole plus amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Relation of Metabolic Rate of Omeprazole and Eradication of Helicobacter Pylori Infection - A Combination of Clinical and Pharmacogenetic Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Helicobacter pylori eradication rate and intragastric pH value

Enrollment: 128
Study Start Date: August 1996
Study Completion Date: February 1998
Primary Completion Date: December 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854451

Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 10043
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jyh-Chin Yang, M.D. Department of Internal Medicine, National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00854451     History of Changes
Other Study ID Numbers: NSC86-2314-B002-169
Study First Received: February 6, 2009
Last Updated: March 1, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
CYP2C19 genotype
intragastric pH
dual therapy
antibiotic resistance

Additional relevant MeSH terms:
Communicable Diseases
Duodenal Ulcer
Helicobacter Infections
Infection
Bacterial Infections
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Gram-Negative Bacterial Infections
Intestinal Diseases
Peptic Ulcer
Amoxicillin
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014