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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastritis Associated With Helicobacter Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dual therapy

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.

Group Type EXPERIMENTAL

vonoprazan 20 mg bid

Intervention Type DRUG

Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.

Amoxicillin 500 mg tid

Intervention Type DRUG

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.

Triple therapy

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.

Group Type ACTIVE_COMPARATOR

vonoprazan 20 mg bid

Intervention Type DRUG

Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.

Amoxicillin 750 mg bid

Intervention Type DRUG

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.

Clarithromycin 200 mg bid

Intervention Type DRUG

Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.

Metronidazole 250 mg bid

Intervention Type DRUG

Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.

Interventions

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vonoprazan 20 mg bid

Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.

Intervention Type DRUG

Amoxicillin 500 mg tid

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.

Intervention Type DRUG

Amoxicillin 750 mg bid

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.

Intervention Type DRUG

Clarithromycin 200 mg bid

Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.

Intervention Type DRUG

Metronidazole 250 mg bid

Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.

Intervention Type DRUG

Other Intervention Names

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takecab® 20 mg bid Sawacillin® 500 mg tid Sawacillin® 750 mg bid Claris® 200 mg bid fragile 250 mg bid

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No