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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021992
Receipt No. 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 2020/10/22

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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
Email 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
Email mebi@aichi-med-u.ac.jp

Sponsor
Institute Aichi medical university
Department of Gastroentelorogy
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 19 Day
Date of IRB
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
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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