UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006319 |
|---|---|
| Receipt number | R000007488 |
| 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 | 2011/10/01 |
| Last modified on | 2011/09/09 20:11:12 |
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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 purpose of the study is compare the effect of esomeprazole and rabeprazole on gastric pH in healthy volunteer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the gastric pH post 1 week administration of esomeprazole or rabeprazole
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Esomeprazole20mg post breakfast for a week over a week - Rabeprazole10mg post breakfast for a week- over a week- Placebo post breakfast for a week
Interventions/Control_2
Esomeprazole20mg post breakfast for a week- over a week- Placebo post breakfast for a week- over a week- post Rabeprazole10mg breakfast for a week
Interventions/Control_3
Rabeprazole10mg post breakfast for a week- over a week- Esomeprazole20mg post breakfast for a week- over a week- Placebo post breakfast for a week
Interventions/Control_4
Rabeprazole10mg post breakfast for a week- over a week- Placebo post breakfast for a week- over a week- post Esomeprazole20mg breakfast for a week
Interventions/Control_5
Placebo post breakfast for a week- over a week- Esomeprazole20mg post breakfast for a week- over a week- post Rabeprazole10mg breakfast for a week
Interventions/Control_6
Placebo post breakfast for a week- over a week- Rabeprazole10mg post breakfast for a week- over a week- post Esomeprazole20mg breakfast for a week
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)healthy adults
2)subjects with written informed consent
Key exclusion criteria
1)Subjects with a history of allegy for esomeprazole or rabeprazole
2)Subjects during taking atazanavir sulfate
3)Subjects with a history of drug allegy
4)Diseases in heart, liver and kidney
5)Subjects with a history of allegy for anesthetic drug
6)Subjects with a history of gastrectomy and/or vagotomy
7)H. pylori infection were confirmed positive
8)Subjects currently have the disease during treatment
9)other not applicatable person recognized by a doctor
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
88-1, Enya, Izumo, Shimane 693-8501
TEL
0853-20-2190
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 and Hepatology
Zip code
Address
88-1, Enya, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 10 | Month | 01 | 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
| 2011 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 09 | Month | 09 | Day |
Last modified on
| 2011 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007488
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