NCT02827942

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Hamamatsu University · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastritis Associated With Helicobacter Pylori

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-12-31
• Completion: 2019-03-31
• First posted: 2016-07-11
• Last updated: 2019-04-09

Locations

1 site across 1 country: Japan