Gastritis Associated With Helicobacter Pylori
Conditions
Keywords
pylori
Brief 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.
Interventions
Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.
DRUGAmoxicillin 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.
DRUGAmoxicillin 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.
DRUGClarithromycin 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.
DRUGMetronidazole 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
Hamamatsu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success or failure of eradication | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Countries
Japan
Outcome results
None listed