Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori

Study Overview
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Brief Summary
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Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid.

Detailed Description
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Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid. CYP2C19 genotypes and susceptibility to CAM are genetically measured. Other factors are also analyzed with reference to eradication rates.

Official Title
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Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori (CREATION Study)

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Drug: rabeprazole-based regimen
* Drug: esomeprazole^based regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients infected with H. pylori who can undergo the eradication therapy Exclusion Criteria: Patients with severe other disorders, cannot undergo eradication therapy, refuses to participate to the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rabeprazole group<br>rabeprazole-based regimen. This group is treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment. | Drug: rabeprazole-based regimen<br>* This group is treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.<br>* Other names: RAC;|
| Active Comparator: esomeprazole group<br>'esomeprazole^based regimen. This group is treated with esomeprazole 20 mg bid , AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment. | Drug: esomeprazole^based regimen<br>* This group is treated with esomeprazole 20 mg bid , AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.<br>* Other names: EAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rates of H. pylori | Success or failure eradication of H. pylori was judged based on the 13C-urea breath test performed 1 month after the treatment. | At 4 weeks after treatment | 
| influence of CYP2C19 genotypes on the eradication rates of H. pylori | influence of CYP2C19 genotypes on the eradication rates of H. pylori are analyzed. CYP2C19 genotypes are classified to the three groups, rapid metabolizer (RM), intermiediate metabolizer (IM) and Poor metabolizer (PM). Because esomperazole is metabolized by CYP2C19, the effects of esomeprazole is influenced by genotypes of CYP2C19. The eradication rates in RMs, IMs and PMs are compared. | At 4 weeks after treatment | 
| Influences of susceptibility of H. pylori strains to clarithromycin (CAM) on the eradication rates of H. pylori | Influences of susceptibility to clarithromycin on eradication rates of H. pylori are analyzed. | At 4 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eradication rates, rabeprazole, esomeprazole