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

Gastritis Associated With Helicobacter Pylori Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827942
• Other study ID #: R15-006
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis
• Gastritis Associated With Helicobacter Pylori

Intervention

Drug:
• vonoprazan 20 mg bid
Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success or failure of eradication	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.	4 to 8 weeks after the end of the eradication therapy
Secondary	Adverse events	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.	1 week