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

Last updated: April 7, 2019
Sponsor: Hamamatsu University
Overall Status: Completed

Phase

3

Condition

Heartburn

Non-ulcer Dyspepsia (Nud)

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT02827942
R15-006
  • Ages 20-90
  • All Genders

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.

Eligibility Criteria

Inclusion

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 foreradication of H. pylori

Exclusion

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

Total Participants: 112
Study Start date:
July 01, 2016
Estimated Completion Date:
March 31, 2019

Study 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.

Connect with a study center

  • Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

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