H. pylori infection and gastro-esophageal reflux desease
Conditions
Interventions
There are four regimens as follows
(1) vonoprazan 20 mg twice daily for 7 days, (2) vonoprazan 20 mg once daily for 7 days, (3) esomeprazole 20 mg twice daily for 7 days, and (4) esomeprazole 20 mg once daily for 7 days. Subjects recei
interventions 1-24"
. "
Interventions 11-24"
are mentioned in "
, because of lack of the space. A clinical research coordinator manages the dosing schedule of each subject. The washout period between the different regimens is at least 2 weeks. In each regimen, 24
regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (4)
Interventions 2
regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (3)
Interventions 3
regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (4)
Interventions 4
regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (2)
Interventions 5
regimen (1), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (3)
Interventions 6
regimen (1), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (2)
Interventions 7
regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen
Sponsors
First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Japanese men and women
Exclusion criteria
Exclusion criteria: Exclusion criteria are any underlying disease, smoking habit, past or present H. pylori infection, and habitual use of any medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is acid inhibition with the four regimens as assessed by 24-hour intragastric pH monitoring on Day7 in each regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes is serum gastrin level on Day 7 with each regimen as a surrogate marker of acid inhibition. | — |
Countries
Japan
Contacts
Public ContactTakahisa Furuta
Hamamatsu University School of Medicine Center for Clinical Research
Outcome results
None listed