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

NCT02767479 | Completed Phase 3

• 1 other identifier: 23-125
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Infection

Keywords

eradication rates; rabeprazole; esomeprazole

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

rabeprazole group

ACTIVE COMPARATOR

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

esomeprazole group

ACTIVE COMPARATOR

'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

Interventions

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.

Also known as: RAC

rabeprazole group

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.

Also known as: EAC

esomeprazole group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients infected with H. pylori who can undergo the eradication therapy

You may not qualify if:

• Patients with severe other disorders, cannot undergo eradication therapy, refuses to participate to the study.

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: May 10, 2016
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

JP (1)