Unique ID issued by UMIN | UMIN000021148 |
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Receipt number | R000024299 |
Scientific Title | A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis. |
Date of disclosure of the study information | 2016/02/23 |
Last modified on | 2017/02/28 21:40:56 |
A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
Japan |
Helicobacter pylori infectious gastritis.
Gastroenterology |
Others
NO
We comparing first-line eradication rate VPZ therapy (VPZ group) with PPI therapy (PPI group) for the treatment of H.pylori infectious gastritis.
Safety,Efficacy
Eradication rates and adverse events.
We evaluate the eradication in all cases using C13-urea breath test (UBT) at eight weeks after completion of the therapy.
We perform a questionnaire to a patient, and we evaluate presence of a diarrhea, loose stool, exanthem, taste disorder, fever, other physical condition defectiveness about the side effect.
Taking medicine compliance.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Treatment
Medicine |
We give vonoprazan 20mg and amoxicillin 750mg and clarithromycin 200mg or 400mg twice daily for 7 days.
We give rabeprazole 20mg and amoxicillin 750mg and clarithromycin 200mg or 400mg of the pack preparation twice a day for 7 days or lansoprazole 30mg and amoxicillin 750mg and clarithromycin 200mg or 400mg that of pack preparation twice a day for 7 days.
20 | years-old | <= |
80 | years-old | > |
Male and Female
H.pylori infectious gastritis.
80 years old or older.
A patient has severe organ dysfunction.
A patient having allergy of the study drug.
A patient that it was judged that eradication was inappropriate on the medical examination of the medical attendant.
200
1st name | |
Middle name | |
Last name | masafumi maruyama |
nagano red cross hospital
gastroenterology
5-22-1, wakasato, nagano, nagano
026-226-4131
m.maruyama@nagano-med.jrc.or.jp
1st name | |
Middle name | |
Last name | masafumi maruyama |
nagano red cross hospital
gastroenterology
5-22-1, wakasato, nagano, nagano
026-226-4131
m.maruyama@nagano-med.jrc.or.jp
nagano red cross hospital
none
Self funding
NO
2016 | Year | 02 | Month | 23 | Day |
Published
Completed
2015 | Year | 04 | Month | 01 | Day |
2016 | Year | 02 | Month | 23 | Day |
2016 | Year | 02 | Month | 22 | Day |
2017 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024299
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