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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002870
Receipt No. R000003504
Scientific Title Effect of meal on pharmacokinetics of omeprazole and lansoprazole.
Date of disclosure of the study information 2010/01/10
Last modified on 2010/12/10

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Basic information
Public title Effect of meal on pharmacokinetics of omeprazole and lansoprazole.
Acronym Effect of meal on pharmacokinetics of omeprazole and lansoprazole.
Scientific Title Effect of meal on pharmacokinetics of omeprazole and lansoprazole.
Scientific Title:Acronym Effect of meal on pharmacokinetics of omeprazole and lansoprazole.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of the study is to examine pharmacokinetics of omeprazole and lansoprazole.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUS of omeprazole and lansoprazole after meal
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 omeprazole at fasting, washout 1-4 week, omeprazole after meal, washout 1-4 week, lansoprazole at fasting, washout 1-4 week, lansoprazole after meal
Interventions/Control_2 omeprazole after meal, washout 1-4 week, omeprazole at fasting, washout 1-4 week, lansoprazole after meal, washout 1-4 week, lansoprazole at fasting
Interventions/Control_3 lansoprazole at fasting, washout 1-4 week, lansoprazoleat after meal, washout 1-4 week, omeprazole at fasting, washout 1-4 week, omeprazoleafter meal
Interventions/Control_4 lansoprazole after meal, washout 1-4 week, lansoprazole at fasting, washout 1-4 week, omeprazole after meal, washout 1-4 week, omeprazole at fasting
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
65 years-old >=
Gender Male
Key inclusion criteria 1. healthy gastroesophageal reflux disease
2. subjects with written informed consent
Key exclusion criteria 1. Subjects with past history of drug allergy including omeprazole and lansoprazole
2. Any liver, kidney, or heart diseases
3. Past history of GI tract surgery or vagotomy
4. Any medications due to any diseases
5. subjects required medications during the study period
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Fujiwara
Organization Osaka City University Graduate School of Medicine
Division name Deaprtment of Gastroenterology,
Zip code
Address 1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Graduate School of Medicine
Division name Deaprtment of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Deaprtment of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japanese Dyspepsia Association
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
2010 Year 01 Month 10 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
2009 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2010 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
2009 Year 12 Month 10 Day
Last modified on
2010 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003504

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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