Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

Hamamatsu University

Status and phase: Completed; Phase 3

Conditions: Gastritis Associated With Helicobacter Pylori

Treatments: Drug: Metronidazole 250 mg bid; Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 500 mg tid; Drug: Clarithromycin 200 mg bid; Drug: Amoxicillin 750 mg bid

Study type: Interventional

Funder types: Other

Identifiers

NCT02827942

R15-006

Details and patient eligibility

About

Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Full description

Patients infected with H. pylori were enrolled and invited to the study.

Patients who have never undergone the H. pylori eradication therapy are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week.

Patients who have ever failed in the eradication of H. pylori by the triple therapy containing clarithromycin are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week.

Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Enrollment: 112 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients infected with H. pylori
• Patients who are not allergic to any of drugs used in this study
• Patients who agree to participate to the study patients who are treatment naive for eradication of H. pylori

Exclusion criteria

• Patients not infected with H. pylori
• Patients who are allergic to any of drugs used in this study
• Patients who do not agree to participate to the study
• Severe general condition, such as renal insufficiency or liver dysfunction
• History of gastrectomy
• Inability to undergo eradication therapy
• Patients who have ever undergone the eradication therapy for H. pylori infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Dual therapy

Experimental group

Description:

Patients assigned to this group are treated with dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week. The eradication rate attained with this regimen is measured.

Treatment:

Drug: Amoxicillin 500 mg tid

Drug: vonoprazan 20 mg bid

Triple therapy

Active Comparator group

Description:

Patients assigned to this group are treated with the triple therapy with vonoprazan 20 mg bid, clarithromycin 200 mg bid and amoxicillin 750 mg bid for 1 week as the first line therapy or the triple therapy with vonoprazan 20 mg bid, metronidazole 250 mg bid and amoxicillin 750 mg bid for 1 week as the second line therapy. The eradication rates attained with these regimens are measured.

Treatment:

Drug: Amoxicillin 750 mg bid

Drug: Clarithromycin 200 mg bid

Drug: vonoprazan 20 mg bid

Drug: Metronidazole 250 mg bid