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

H. Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767479
• Other study ID #: 23-125
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2014
• Last updated: June 20, 2017
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: June 2017
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• H. Pylori Infection

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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