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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009065
Receipt No. R000010639
Scientific Title The effect of esomeprazole on acid suppression in Japanese-evaluation with the endoscopic gastrin test, EGT-
Date of disclosure of the study information 2012/10/15
Last modified on 2014/10/10

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Basic information
Public title The effect of esomeprazole on acid suppression in Japanese-evaluation with the endoscopic gastrin test, EGT-
Acronym The rate of acid suppression of administration of esomeprazole.
Scientific Title The effect of esomeprazole on acid suppression in Japanese-evaluation with the endoscopic gastrin test, EGT-
Scientific Title:Acronym The rate of acid suppression of administration of esomeprazole.
Region
Japan

Condition
Condition Gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the rate of acid suppression of esomeprazole administration in various dosage and timing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the rate of acid suppression at the steady state(at 14:00 on day7) among each group.
Key secondary outcomes To compare the rate of acid suppression of esomeprazole at 8:00 on day15* among each group.
*at 8:00 on day15: Twenty-four hours after last administration for once daily and 10 hours after last administration for twice daily
To evaluate the background factors that affect the acid suppression, such as H.pylori infecton, CYP2C19 polymophism in three groups.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00.-wash out 2-4week esomeprazole10mg before meal once a day at 08:00
Interventions/Control_2 esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00
Interventions/Control_3 esomeprazole20mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week esomeprazole10mg bofore meal once a day at 08:00
Interventions/Control_4 esomeprazole20mg before meal once a day at 08:00-wash out 2-4week- esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00
Interventions/Control_5 esomeprazole10mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00-wash out 2-4week-esomeprazole20mg before meal once a day at 08:00
Interventions/Control_6 esomeprazole10mg before meal once a day at 08:00-wah out 2-4wek-esomeprazole20mg before meal once a day at 08:00-wash out 2-4week-esomeprazole20mg before meal twice a day at 08:00 and 22:00
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male
Key inclusion criteria 1. healthy volunteer
1. Subjects provide written voluntary consent to participate in the study after sufficient written and oral explanation.
Key exclusion criteria 1. Subjects with past history of drug allergy
2. Subjects with hepatic, renal, or cardiac disorder
3. Subjects with a history of gastrectomy and/or vagotomy
4. Subjects who are on any treatment
5. Subjects who need to receive any drugs other thanthe study drug during the study.
6. Others as judged inappropriate by the investigator(s)
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Koike
Organization Tohoku University Graduate Schooi of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Snedai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Koike
Organization Tohoku University Graduate Schooi of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Snedai
TEL
Homepage URL
Email

Sponsor
Institute Division of Gastroenterology, Tohoku University Graduate Schooi of Medicine
Institute
Department

Funding Source
Organization Non-profit Organization for Promotion of Gastrointestinal Disease Treatment Research
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 東北大学病院 消化器内科

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 15 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
2012 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 10 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
2012 Year 10 Month 09 Day
Last modified on
2014 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010639

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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