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

NCT02827942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-04-09

No results posted yet for this study

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.

Conditions

  • Gastritis Associated With Helicobacter Pylori

Interventions

DRUG

vonoprazan 20 mg bid

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

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.

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.

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.

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.

Sponsors & Collaborators

  • Hamamatsu University

    lead OTHER

Principal Investigators

  • Takahisa Furuta, MD, PhD · Hamamatsu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02827942 on ClinicalTrials.gov