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Completed

NCT Number: NCT02827942

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

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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Key information

Conditions

Gastritis Associated With Helicobacter Pylori

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vonoprazan 20 mg bid

Drug

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

Other names: takecab® 20 mg bid

Amoxicillin 500 mg tid

Drug

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

Other names: Sawacillin® 500 mg tid

Amoxicillin 750 mg bid

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.

Other names: Sawacillin® 750 mg bid

Clarithromycin 200 mg bid

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.

Other names: Claris® 200 mg bid

Metronidazole 250 mg bid

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.

Other names: fragile 250 mg bid

Primary outcomes

  1. The success or failure of eradication

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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