UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002870 |
|---|---|
| Receipt number | 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 13:36:51 |
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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
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
Sponsor or person
Institute
Deaprtment of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003504
