Unique ID issued by UMIN | UMIN000013484 |
---|---|
Receipt number | R000015746 |
Scientific Title | Comparison of the night acid suppresion between Proton pump inhibitors in Helicobacter pylori negative healthy volunteers |
Date of disclosure of the study information | 2014/12/30 |
Last modified on | 2014/03/22 18:14:50 |
Comparison of the night acid suppresion between Proton pump inhibitors in Helicobacter pylori negative healthy volunteers
IZUMO night pH study
Comparison of the night acid suppresion between Proton pump inhibitors in Helicobacter pylori negative healthy volunteers
IZUMO night pH study
Japan |
Gastroesophageal reflux diseases (GERD)
Gastroenterology |
Others
NO
evaluation of intra-gastric pH following single oral administrations of rabeprazole and esomeprazole
Efficacy
Confirmatory
Pragmatic
Not applicable
evaluation of intra-gastric pH following single oral administrations of rabeprazole and esomeprazole on First day
Interventional
Cross-over
Randomized
Cluster
Double blind -all involved are blinded
Active
YES
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Medicine |
Esomeprazole 20mg once daily - wash out 7 days over - Rabeprazole 10mg once daily
Rabeprazole 10mg once daily - wash out 7 days over - Esomeprazole 20mg once daily
20 | years-old | <= |
50 | years-old | > |
Male and Female
1. healthy adults
2. BMI ranged from 19kg/m2 to 28kg/m2
3. without upper abdominal symptom
4. non smokers
5. 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
80
1st name | |
Middle name | |
Last name | Yoshikazu Kinoshita |
Shimane University Faculty of Medicine
Department of Internal Medicine II
89-1 Enya-cho, Izumo, Shimane 693-8501
0853-20-2190
kinosita@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Kenji Furuta |
Shimane University Faculty of Medicine
Department of Internal Medicine II
89-1 Enya-cho, Izumo, Shimane 693-8501
0853-20-2190
kmyhy5@shimane-med.ac.jp
Shimane University Faculty of Medicine,
Department of Internal Medicine II
Eisai Co.,Ltd
Profit organization
NO
北海道大学(北海道)、日本医科大学(東京)、横浜市立大学(神奈川)、浜松医科大学(静岡)、大阪医科大学(大阪)、大阪市立大学(大阪)、島根大学(島根)、佐賀大学(佐賀)
2014 | Year | 12 | Month | 30 | Day |
Partially published
Completed
2011 | Year | 11 | Month | 25 | Day |
2012 | Year | 01 | 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 |
2014 | Year | 03 | Month | 22 | Day |
2014 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015746
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