UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000853 |
|---|---|
| Receipt number | R000001024 |
| Scientific Title | Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers |
| Date of disclosure of the study information | 2008/01/01 |
| Last modified on | 2008/09/22 11:14:44 |
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Basic information
Public title
Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Acronym
Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Scientific Title
Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Scientific Title:Acronym
Randomized control trial of Rabeprazole for prevention of aspirin-associated ulcers
Region
| Japan |
Condition
Condition
Aspirin-associated ulcers
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of rabeprazole for prevention of aspirin associated gastroduodenal ulcers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of gastroduodenal ulcers
Key secondary outcomes
gastroduodenal mucosal damage assessed by modified Lanza's score
hemorrhagic gastroduodenal ulcer
symptoms asssessed by Gastrointestinal Symptoms Rating Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole
3 months
10mg/day
once per day
Interventions/Control_2
no treatment
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
Patients who is going to be introduced low-dose aspirin for more than four months
Key exclusion criteria
History of peptic ulcer diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
University of Tokyo
Division name
Clinical Research Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
University of Tokyo
Division name
Clinical Research Center
Zip code
Address
TEL
Homepage URL
keiji-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology
University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 01 | 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
| 2007 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 16 | Day |
Last modified on
| 2008 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001024
