UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000761 |
|---|---|
| Receipt number | R000000912 |
| Scientific Title | Study of prevention in aspirin ulcer of the gastro-duodenum |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2007/07/03 23:47:58 |
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Basic information
Public title
Study of prevention in aspirin ulcer of the gastro-duodenum
Acronym
Prevention study of aspirin ulcer
Scientific Title
Study of prevention in aspirin ulcer of the gastro-duodenum
Scientific Title:Acronym
Prevention study of aspirin ulcer
Region
| Japan |
Condition
Condition
patients taking aspirin
Classification by specialty
| Gastroenterology | Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate that proton pump inhibitor (PPI) is superior to histamin antagonist (H2 blocker) for prevention of gastro-duodenal ulcer in Japanese patients taking aspirin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
presence of gastro-duodenal erosion or ulcer in endoscopic examination
Key secondary outcomes
estimation of Hericobactor pyroli
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 year lansoplazole:15mg/day
Interventions/Control_2
1 year famotidine:40mg/day
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients taking low-dose aspirin, age range (20-85 year-old)
Key exclusion criteria
Patients were excluded the following criteria: inadequate organ functions, pregnancy, uncontrolable DM, malignancy, state after gastrectomy, and receiving stereid or warfarin.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kaneko |
Organization
Showa University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8535
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Konishi |
Organization
Showa University School of MedicineShowa University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8535
Homepage URL
http://www.showa-u.ac.jp
konishigi66@aol.com
Sponsor or person
Institute
Second Department of Internal Medicine, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 01 | 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
Date of protocol fixation
| 2005 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 03 | Day |
Last modified on
| 2007 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000912
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
