Unique ID issued by UMIN | UMIN000008114 |
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Receipt number | R000009552 |
Scientific Title | Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers |
Date of disclosure of the study information | 2012/06/06 |
Last modified on | 2012/06/06 18:55:39 |
Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers
Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Alimentary Tract Lesions
Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Esophagitis, Peptic Ulcers, Small Intestinal Lesions in Volunteers
Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Alimentary Tract Lesions
Japan |
NSAID induced Alimentary Tract Lesions
Gastroenterology |
Others
NO
We investigate the efficacy of irsogladine and omeprazole on esophagitis, peptic ulcers, small bowel intestinal lesions induced by short-term NSAID administration.
Efficacy
The number of small intestinal mucosal breaks evaluated in the capsule endoscope.
Interventional
Parallel
Randomized
Single blind -investigator(s) and assessor(s) are blinded
Placebo
2
Prevention
Medicine |
irsogladine 4mg/day and dicrofenacNa 75mg/day for 2 weeks in oral administration
omeprazole 10mg/day and dicrofenacNa75mg/day for 2 weeks in oral administration
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining
consent
2) Subjects from whom fully informed written consent based on their full understanding and their
own voluntary will was obtained when participating this study
3)Subjects who had taken no medication during the 1-month period before the start of this study
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) Subjects with alcohol or chemical dependencies
6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal
obstruction on other tests
7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body
8) Subjects whom otherwise the investigator determined ineligible as the subject
32
1st name | |
Middle name | |
Last name | Kazuhide Higuchi |
Osaka Medical College
Second Department of Internal Medicine
2-7 Daigakumachi Takatsuki Osaka 569-8686 Japan
1st name | |
Middle name | |
Last name |
Osaka Medical College
Second Department of Internal Medicine
Second Department of Internal Medicine, Osaka Medical College
None
Self funding
NO
2012 | Year | 06 | Month | 06 | Day |
Published
Completed
2009 | Year | 09 | Month | 29 | Day |
2009 | Year | 10 | Month | 01 | Day |
2012 | Year | 06 | Month | 06 | Day |
2012 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009552
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