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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013165
Receipt No. 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

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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
Email 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
Email ishimura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine, Department of Internal Medicine II
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015351

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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