Unique ID issued by UMIN | UMIN000009230 |
---|---|
Receipt number | R000010839 |
Scientific Title | Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study. |
Date of disclosure of the study information | 2012/10/31 |
Last modified on | 2013/11/15 22:56:51 |
Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study.
Preventive efficacy for aspirin induced gastric mucosal lesions by irsogladine
Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study.
Preventive efficacy for aspirin induced gastric mucosal lesions by irsogladine
Japan |
Gastritis
Gastroenterology | Adult |
Others
NO
We evaluate whether irsogladine or PPI can prevent gastritis induced by 2 weeks' administration of aspirin in healthy volunteers.
Efficacy
LANZA scores at 2 weeks of the treatment
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Placebo
3
Prevention
Medicine |
Aspirin 100mg/day p.o. for 2 weeks
Aspirin 100mg/day and Irsogladine 4mg/day p.o. for 2 weeks
Aspirin 100mg/day and Lansoprazole 15mg/day p.o. for 2 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
H. pylori negative healthy subjects aged from 20 to 65 years when the written informed consent is obtained
1)Subjects with a history of peptic ulcer or gastrointestinal bleeding
2)Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease
3)Subjects with a history of gastrointestinal surgery other than appendectomy
4)Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs
5)Pregnancy or Lactation
6)Subjects whom otherwise the investigator determined ineligible as the subject
45
1st name | |
Middle name | |
Last name | Kazunari Murakami |
Faculty of Medicine, Oita University
Department of Gastroenterology
1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita
097-586-6193
murakam@oita-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Mizukami |
Faculty of Medicine, Oita University
Department of Gastroenterology
1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita
097-586-6193
mizkaz0809@oita-u.ac.jp
Department of Gastroenterology,
Faculty of Medicine, Oita University
None
Self funding
NO
2012 | Year | 10 | Month | 31 | Day |
Unpublished
Terminated
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 09 | Month | 30 | Day |
2012 | Year | 10 | Month | 31 | Day |
2013 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010839