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

H

Hamamatsu University

Status and phase

Completed
Phase 3

Conditions

H. Pylori Infection

Treatments

Drug: esomeprazole^based regimen
Drug: rabeprazole-based regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT02767479
23-125

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

rabeprazole group
Active Comparator group
Description:
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.
Treatment:
Drug: rabeprazole-based regimen
esomeprazole group
Active Comparator group
Description:
'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.
Treatment:
Drug: esomeprazole^based regimen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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