UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021992 |
|---|---|
| Receipt number | R000025130 |
| Scientific Title | A prospective ramdomized control trial of comparing PPI vesus P-CAB in the treatment of hemorrhagic peptic ulcer disease |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2021/04/23 16:39:18 |
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Basic information
Public title
A prospective ramdomized control trial of comparing PPI vesus P-CAB in the treatment of hemorrhagic peptic ulcer disease
Acronym
PPI versus P-CAB in the treatment of hemorrhagic peptic ulcer
Scientific Title
A prospective ramdomized control trial of comparing PPI vesus P-CAB in the treatment of hemorrhagic peptic ulcer disease
Scientific Title:Acronym
PPI versus P-CAB in the treatment of hemorrhagic peptic ulcer
Region
| Japan |
Condition
Condition
hemorrhagic peptic ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison between PPI and P-CAB in treatment for hemorrhagic peptic ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The reduction rate of ulcer for a week
Key secondary outcomes
The rate of re-bleeding, the day of hospitalization, the rate of blood transfusion, The transfer rate of surgery or IVR, The influence of anti-platelet/anti-coaglant,The cure rate for 28 days, The cure rate for 56 days
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 not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients of hemorrhagic peptic ulcer are treated by PPI, after endoscopic hemostasis
Interventions/Control_2
Tht patients of hemorrhagic peptic ulcer are treated by P-CAB, after endoscopic hemostasis
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients of hemorragic peptic ulcer are done endoscopic hemostasis.
The patients who agree with this study.
Key exclusion criteria
The patients of hemorrhagic peptic ulcer are hard to do endoscopic hemostasis.
The patients can not take medicine.
The patients who do not agree with this study.
Tha patients who take atazanavir sulfate or rirupibirin hydrochloride.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Department of Gastroentelorogy
Zip code
4801195
Address
1-1 yazako-karimata Nagakute-city Aichi prefecture
TEL
0561-62-3311
mebi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Department of Gastroentelorogy
Zip code
4801195
Address
1-1 yazako-karimata Nagakute-city Aichi prefecture Japan
TEL
0561-62-3311
Homepage URL
mebi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Department of Gastroentelorogy
Institute
Department
Personal name
Funding Source
Organization
None
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
Aichi medical university
Address
1-1 Yazakokarimata Nagakute Aichi
Tel
0561623311
mebi@aichi-med-u.ac.jp
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
| 2016 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
5
Results
canceled
Results date posted
| 2020 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
gastric ulcer
Participant flow
informed concent
Adverse events
none
Outcome measures
impossible
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025130
| Research Plan | |
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| Registered date | File name |
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