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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02767479
Enrollment
200
Registered
2016-05-10
Start date
2012-07-31
Completion date
2016-04-30
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Keywords

eradication rates, rabeprazole, esomeprazole

Brief summary

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

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.

Interventions

DRUGrabeprazole-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.

DRUGesomeprazole^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.

Sponsors

Hamamatsu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rates of H. pyloriAt 4 weeks after treatmentSuccess or failure eradication of H. pylori was judged based on the 13C-urea breath test performed 1 month after the treatment.
influence of CYP2C19 genotypes on the eradication rates of H. pyloriAt 4 weeks after treatmentinfluence 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.
Influences of susceptibility of H. pylori strains to clarithromycin (CAM) on the eradication rates of H. pyloriAt 4 weeks after treatmentInfluences of susceptibility to clarithromycin on eradication rates of H. pylori are analyzed.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026