UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014577 |
|---|---|
| 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 |
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Basic information
Public title
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Acronym
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Scientific Title
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Scientific Title:Acronym
Study of the effect of Proton Pump Inhibitor (PPI) on intra-gastric pH in healthy volunteer - Comparison of Esomeprazole and Rabeprazole -
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease(GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpuse of this study is clarify the difference in inhibitory effect of gastric acid secretion with esomeprazole and rabeprazole
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of intra-gastric pH following single oral pre- and postprandial administrations of esomeprazole and rabeprazole on 7th day
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo once daily(7days)-wash out 7days over-Esomeprazole20mg once daily after breakfast(7days)-wash out 7days over-Esomeprazole20mg once daily before breakfast(7days)
Interventions/Control_2
7days over-Rabeprazole10mg once daily after breakfast(7days)-wash out 7days over-rabeprazole10mg once daily before breakfast(7days)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.healthy adults
2.without upper abdominal symptom
3.without Helicobacter pylori
Key exclusion criteria
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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Furuta |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
Address
89-1 Enya-cho, Izumo-shi, Shimane 693-8501, Japan
TEL
0853-20-2190
Homepage URL
kfuruta@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Second Department of Internal Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 16 | Day |
Last modified on
| 2014 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015803
