UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013165 |
|---|---|
| Receipt number | R000015351 |
| Scientific Title | A study on the effect of proton pump inhibitors on intra-gastric pH in healthy adults: comparison of rabeprazole and esomeprazole |
| Date of disclosure of the study information | 2014/02/19 |
| Last modified on | 2015/02/20 19:28:04 |
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Basic information
Public title
A study on the effect of proton pump inhibitors on intra-gastric pH in healthy adults: comparison of rabeprazole and esomeprazole
Acronym
Comparison of rabeprazole and esomeprazole
Scientific Title
A study on the effect of proton pump inhibitors on intra-gastric pH in healthy adults: comparison of rabeprazole and esomeprazole
Scientific Title:Acronym
Comparison of rabeprazole and esomeprazole
Region
| Japan |
Condition
Condition
Gastroesophageal reflux diseases (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of intra-gastric pH after twice daily administration of Rabeprazole or Esomeprazole
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 after administration of Rabeprazole or Esomeprazole for 5 days
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Esomeprazole 20mg twice daily for 5 days-over 6 days-Rabeprazole 20mg twice daily for 5 days- over 6 days- Rabeprazole 10mg twice daily for 5 days
Interventions/Control_2
Rabeprazole 10mg twice daily for 5 days- over 6 days- Esomeprazole 20mg twice daily for 5 days- over 6 days- Rabeprazole 20mg twice daily for 5 days
Interventions/Control_3
Rabeprazole 20mg twice daily for 5 days- over 6 days- Rabeprazole 10mg twice daily for 5 days- over 6 days- Esomeprazole 20mg twice daily for 5 days
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. healthy adults
2. subjects with written informed concent
3. subjects without Helicobacter pylori infection
4. subjects with CYP2C19 extensive metabolizer
5. subjects with BMI ranged from 18.5kg/m2 to 25.0kg/m2
Key exclusion criteria
1. subjects with taking drugs affecting gastrointestinal motor function
2. subjects with upper abdominal symptom
3. subjects with a history gastrectomy
4. subjects who cannot stop smoking during the study period
5. subjects who are not eligible for participation judged by a doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine II
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
ishimura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine II
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine, Department of Internal Medicine II
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 02 | Month | 19 | 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
There were no statistically significant difference regarding primary outcome between Rabeprazole and Esomeprazole. No adverse events were reported in all enrolled subjects.
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 24 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 14 | Day |
Last modified on
| 2015 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015351
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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