Unique ID issued by UMIN | UMIN000008883 |
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Receipt number | R000010425 |
Scientific Title | Influence of proton pump inhibitor on NSAID-induced small-intestinal mucosal injuries; prospective, double-blind, placebo controlled study |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2015/05/08 21:11:00 |
Influence of proton pump inhibitor on NSAID-induced small-intestinal mucosal injuries; prospective, double-blind, placebo controlled study
PPI-NSAID Kyushu University study (PINK study)
Influence of proton pump inhibitor on NSAID-induced small-intestinal mucosal injuries; prospective, double-blind, placebo controlled study
PPI-NSAID Kyushu University study (PINK study)
Japan |
NSAID-induced small bowel mucosal injury
Gastroenterology |
Others
NO
This study is aimed to ascertain the influence of PPI on NSAID-induced small bowel mucosal injury using capsule endoscopy. In this prospective, double-blind, placebo controldomized study, healthy subjects are randomly assigned to two groups, the one taking celecoxib plus rabeprazole and the other taking celecoxib plus placebo.
Efficacy
The number and incidence of small bowel pathologies (ulcer, hemorrhage and mucosal break) under capsule endoscopy after 2 weeks medication.
Abdominal symptoms and laboratory data.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Central registration
2
Treatment
Medicine |
Subjects in NSAID group are administered celecoxib 200mg twice per day and placebo 20mg once per day for two weeks.
Subjects in NSAID plus PPI group are administered celecoxib 200mg twice per day and rabeprazole 20mg once per day for two weeks.
20 | years-old | <= |
75 | years-old | > |
Male and Female
Healthy volunteers obtained written informed consent
1) Subjects with a history of peptic ulcers
2) Subjects treated by corticosteroid (>10mg/day of prednisolone)
3) Subjects treated continuously with NSAIDs
4) Subjects treated with aspirin
5) Subjects with a history of aspirin-induced asthma
6) Subjects allergic to sulufonamids
7) Subjects treated with anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc)
8) Subjects with gastrointestinal stenosis or severe adhesion
9) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease
10) Pregnant and nursing women
11) Subjects with other disorders who are judged inappropriate for the participation of the study
60
1st name | |
Middle name | |
Last name | Takanari Kitazono |
Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5261
1st name | |
Middle name | |
Last name | Takayuki Matsumoto, Motohiro Esaki, Yuji Maehata, Ema Washio |
Kyushu University
Department of Medicine and Clinical Science
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5261
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Other
Japan
Fukuoka Sanno Hospital
YES
FS30
Fukuoka Sanno Hospital
福岡山王病院(福岡県)
2012 | Year | 10 | Month | 01 | Day |
Partially published
Completed
2012 | Year | 07 | Month | 13 | Day |
2012 | Year | 10 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2012 | Year | 09 | Month | 09 | Day |
2015 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010425
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