Unique ID issued by UMIN | UMIN000014577 |
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Receipt number | R000015803 |
Scientific Title | Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole - |
Date of disclosure of the study information | 2014/07/16 |
Last modified on | 2014/07/16 23:57:05 |
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Japan |
Gastroesophageal reflux disease(GERD)
Gastroenterology |
Others
NO
The purpuse of this study is clarify the difference in inhibitory effect of gastric acid secretion with esomeprazole and rabeprazole
Efficacy
Confirmatory
Pragmatic
Not applicable
evaluation of intra-gastric pH following single oral pre- and postprandial administrations of esomeprazole and rabeprazole on 7th day
Interventional
Cross-over
Randomized
Double blind -all involved are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
Placebo once daily(7days)-wash out 7days over-Esomeprazole20mg once daily after breakfast(7days)-wash out 7days over-Esomeprazole20mg once daily before breakfast(7days)
7days over-Rabeprazole10mg once daily after breakfast(7days)-wash out 7days over-rabeprazole10mg once daily before breakfast(7days)
20 | years-old | <= |
Not applicable |
Male and Female
1.healthy adults
2.without upper abdominal symptom
3.without Helicobacter pylori
1.with taking drugs affecting gastrointestinal motor function
2.with a history gastrectomy
3.complicated with severe cardiac, hematologic, renal, hepatic diseases or malignant tumor
4.possibility to be pregnant or pregnant women
5.subjects who are not eligible for participation judged by a doctor
30
1st name | |
Middle name | |
Last name | Yoshikazu Kinoshita |
Shimane University Faculty of Medicine
Second Department of Internal Medicine
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
0853-20-2190
kinosita@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Kenji Furuta |
Shimane University Faculty of Medicine
Department of Gastroenterology
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
0853-20-2190
kfuruta@med.shimane-u.ac.jp
Shimane University Faculty of Medicine
Second Department of Internal Medicine
Shimane University Faculty of Medicine
Second Department of Internal Medicine
Other
NO
2014 | Year | 07 | Month | 16 | Day |
Unpublished
Preinitiation
2013 | Year | 10 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 07 | Month | 16 | Day |
2014 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015803
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