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Completed

NCT Number: NCT02767479

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

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.

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Key information

Conditions

H. Pylori Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rabeprazole-based regimen

Drug

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.

Other names: RAC

esomeprazole^based regimen

Drug

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.

Other names: EAC

Primary outcomes

  1. Eradication rates of H. pylori

    Time frame: At 4 weeks after treatment

    Success or failure eradication of H. pylori was judged based on the 13C-urea breath test performed 1 month after the treatment.

  2. influence of CYP2C19 genotypes on the eradication rates of H. pylori

    Time frame: At 4 weeks after treatment

    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.

  3. Influences of susceptibility of H. pylori strains to clarithromycin (CAM) on the eradication rates of H. pylori

    Time frame: At 4 weeks after treatment

    Influences of susceptibility to clarithromycin on eradication rates of H. pylori are analyzed.

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 10, 2016
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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