UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001679 |
|---|---|
| Receipt number | R000002027 |
| Scientific Title | Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury |
| Date of disclosure of the study information | 2009/02/02 |
| Last modified on | 2014/08/03 08:59:14 |
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Basic information
Public title
Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Acronym
Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Scientific Title
Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Scientific Title:Acronym
Effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury
Region
| Japan |
Condition
Condition
Patients having taken low-dose aspirin
Classification by specialty
| Gastroenterology | Cardiology | Endocrinology and Metabolism |
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the improvement of gastroduodenal mucosal injury in patients having taken low-dose aspirin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of endoscopic finding before and 4 weeks after initiating rabeprazole or sucralfate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole 10mg/day, 4 weeks
Interventions/Control_2
sucralfate 3g/day, 4 weeks
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 have taken low-dose aspirin regularly
Key exclusion criteria
1.below 20 years of age
2.contraindication against rabeprazole and sucralfate
3.malignancy
4.pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Kuyama |
Organization
Teikyo University School of Medicine
Division name
Internal Medicine
Zip code
Address
2-11-1 Kaga Itabashi-ku Tokyo
TEL
03-3964-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University School of Medicine
Division name
Internal Medicine
Zip code
Address
TEL
Homepage URL
ymmt@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of Medicine
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
| 2009 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | 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
| 2009 | Year | 02 | Month | 01 | Day |
Last modified on
| 2014 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002027
