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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014577
Receipt No. 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

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

Sponsor
Institute Shimane University Faculty of Medicine
Second Department of Internal Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015803

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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