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

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)

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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