![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000001678 |
Receipt No. | R000002026 |
Scientific Title | Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin |
Date of disclosure of the study information | 2009/02/02 |
Last modified on | 2014/08/03 |
Basic information | ||
Public title | Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin | |
Acronym | Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin | |
Scientific Title | Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin | |
Scientific Title:Acronym | Preventive effect of rabeprazole and sucralfate on gastroduodenal mucosal injury in patients taking low-dose aspirin | |
Region |
|
Condition | |||||
Condition | Patients who have plan to receive low-dose aspirin | ||||
Classification by specialty |
|
||||
Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the preventive effect of rabeprazole and sucralfate on low-dose aspirin-related gastroduodenal mucosal injury |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change of endoscopic finding before and 4 weeks after initiating low-dose aspirin (Comparison between rabeprazole and 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 | Prevention | |
Type of intervention |
|
|
Interventions/Control_1 | rabeprazole: 10mg/day, 4 week
given with aspirin 100mg/day |
|
Interventions/Control_2 | scralfate 3g/day, 4 week
given with aspirin 100mg/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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients who have a plan to receive low-dose aspirin | |||
Key exclusion criteria | 1.taking low-dose aspirin
2.below 20 years of age 3.contraindication against rabeprazole and sucralfate 4.malignancy 5.pregnancy |
|||
Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Teikyo University School of Medicine | ||||||
Division name | Internal Medicine | ||||||
Zip code | |||||||
Address | 2-11-1 Kaga Itabashiku Tokyo | ||||||
TEL | 03-3964-1211 | ||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Teikyo University School of Medicine | ||||||
Division name | Internal Medicine | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
ymmt@med.teikyo-u.ac.jp |
Sponsor | |
Institute | Department of Internal Medicine, Teikyo University School of Medicine |
Institute | |
Department |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002026 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |