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

Phase 3

Completed

• Conditions: Gastritis Associated With Helicobacter Pylori
• Interventions: Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 500 mg tid; Drug: Amoxicillin 750 mg bid; Drug: Clarithromycin 200 mg bid; Drug: Metronidazole 250 mg bid

• Registration Number: NCT02827942
• Lead Sponsor: Hamamatsu University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-12
• Study Start: 2016-07-01
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual therapy	Amoxicillin 500 mg tid	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.
Triple therapy	vonoprazan 20 mg bid	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.
Triple therapy	Clarithromycin 200 mg bid	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.
Dual therapy	vonoprazan 20 mg bid	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.
Triple therapy	Metronidazole 250 mg bid	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.
Triple therapy	Amoxicillin 750 mg bid	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.

Primary Outcome Measures

Name	Time	Method
The success or failure of eradication	4 to 8 weeks after the end of the eradication therapy	Success or failure of eradication of H. pylor is to be diagnosed at 4 to 8 weeks after the end of the eradication therapy by13C-urea breath test.

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 week	Adverse events related that happen during 1 week-treatments, such as diarrhea, loose stool, abdominal pain, and allergic reaction are checked by interview when patients visit the hospital to undergo the 13C-urea breath test for the diagnosis of success or failure of eradication of H. pylori.

Trial Locations

Locations (1)

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Shizuoka, Japan