Unique ID issued by UMIN | UMIN000019835 |
---|---|
Receipt number | R000022911 |
Scientific Title | A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection |
Date of disclosure of the study information | 2015/11/18 |
Last modified on | 2019/12/03 11:44:08 |
A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
The efficacy of vonoprazan for ESD-induced ulcer
A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
The efficacy of vonoprazan for ESD-induced ulcer
Japan |
Gastric ulcer
Gastroenterology |
Others
NO
compare the efficacy of the combined therapy with vonoprazan and rebamipide to lansoprazole and rebamipide for artificial gastric ulcer after endoscopic submucosal dissection
Efficacy
Confirmatory
Explanatory
Not applicable
Cure rates of gastric ulcer at 4 weeks after treatment
Cure rates of gastric ulcer at 8 weeks after treatment, reduction rates of gastric ulcer at 4 and 8 weeks after treatment, incidence rate of delayed bleeding
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
vonoprazan 20mg/day for 4 to 8 weeks p.o.
rebamipide 300mg/day for 4 to 8 weeks p.o.
lansoprazole 30mg/day for 4 to 8 weeks p.o.
rebamipide 300mg/day for 4 to 8 weeks p.o.
20 | years-old | <= |
90 | years-old | > |
Male and Female
Patients aged 20 to 89 who scheduled for ESD for gastric adenoma or early cancer
Patients with
1)the history of surgery for upper GI
2)concomitant administration of anticoagulants
3)concomitant administration of PPI
4)the history of radiotherapy or chemotherapy within 3 months
5)gastric hyperacidity such as Zollinger-Ellison syndorome
6)allergy to PPI or rebamipide
130
1st name | |
Middle name | |
Last name | Junichi Akiyama |
National Center for Global Health and Medicine
Gastroenterological medicine
1-21-1 toyama,shinjyuku,tokyo
03-3202-7181
jakiyama.ncgm@gmail.com
1st name | |
Middle name | |
Last name | Kazuhiro Watanabe |
National Center for Global Health and Medicine
Gastroenterological medicine
1-21-1 toyama,shinjyuku,tokyo
03-3202-7181
kazuw0229@gmail.com
National Center for Global Health and Medicine
none
Self funding
NO
国立国際医療研究センター
2015 | Year | 11 | Month | 18 | Day |
Unpublished
Terminated
2015 | Year | 07 | Month | 13 | Day |
2015 | Year | 07 | Month | 13 | Day |
2015 | Year | 08 | Month | 01 | Day |
2019 | Year | 04 | Month | 01 | Day |
2015 | Year | 11 | Month | 18 | Day |
2019 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022911