Unique ID issued by UMIN | UMIN000033984 |
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Receipt number | R000038751 |
Scientific Title | Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study |
Date of disclosure of the study information | 2018/09/01 |
Last modified on | 2018/09/01 13:21:19 |
Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study
Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury
Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study
Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury
Japan |
LDA-induced small intestinal mucosal injury
Gastroenterology |
Others
NO
The aim of this clinical study was to investigate how high-dose ES affects LDA-induced small intestinal mucosal injury.
Efficacy
Severity of small intestinal mucosal injury using small bowel capsule endoscopy
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
The subjects in group A received LDA (100 mg) once daily.
The subjects in group B received LDA and 4.0 g of ES (1.0 g four times daily).
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) freely provided informed consent on the basis of their full understanding of the study protocol, and 2) had no history of medication use during the month before enrolment in the study
1) history of peptic ulcer or gastrointestinal bleeding; 2) significant hepatic, renal, heart, or respiratory disease; 3) history of gastrointestinal surgery other than appendectomy; 4) use of oral histamine H2-receptor antagonists, gastrointestinal kinetic agents, and gastric mucoprotective drugs within 2 weeks before the study; 5) use of oral non-steroidal anti-inflammatory drugs (NSAIDs), steroids, anticholinergic drugs, anticancer drugs, or antithrombotic drugs within 4 weeks prior; 6) alcohol or chemical dependency; 7) history of gastrointestinal obstruction; 8) refusal to consent to the surgery that would be required if the capsule endoscope was retained in the body; and 9) determination by the investigator, at his/her discretion, that a subject was ineligible for participation in the study for any reason.
30
1st name | |
Middle name | |
Last name | Kazuhide Higuchi |
Osaka medical college
Second department of internal medicine
2-7, Daigaku-machi, Takatsuki
072-683-1221
higuchi@osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Ota |
Osaka medical college
Second department of internal medicine
2-7, Daigaku-machi, Takatsuki
072-683-1221
clash_kaz@yathoo.co.jp
Osaka medical college
Osaka medical college
Self funding
NO
2018 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 10 | Month | 04 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 09 | Month | 01 | Day |
2018 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038751
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