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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004858
Receipt No. R000005781
Scientific Title Compariosn with the effect of PPI in the use on demand using BRAVO system
Date of disclosure of the study information 2011/01/11
Last modified on 2012/01/05

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Basic information
Public title Compariosn with the effect of PPI in the use on demand using BRAVO system
Acronym Compariosn with the effect of PPI
Scientific Title Compariosn with the effect of PPI in the use on demand using BRAVO system
Scientific Title:Acronym Compariosn with the effect of PPI
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison with two PPIs, lansoprazole and rabeprazole
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The pH3 holding time in gastric pH
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lansoprazole
Interventions/Control_2 rabeprazole
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Health volunteer
Within NOrmal Limit by GS examination
Helicobacter Negative
Key exclusion criteria (1) Allergy for lansoprazole or rabeprazole
(2) Severe liver disease
(3) patients with treatment of malignant disease
(4) Pregnant or Nursing a baby
(5) Use of PPI or H2B in a month
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba City, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Chiba University Hospital
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
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 11 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 Completed
Date of protocol fixation
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 01 Month 11 Day
Last modified on
2012 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005781

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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