UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005749 |
|---|---|
| Receipt number | R000006786 |
| Scientific Title | A study to evaluate the benefit of omeprazole in the prevention of bleeding from esophageal ulcer after esophageal varices |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2011/06/10 09:34:09 |
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Basic information
Public title
A study to evaluate the benefit of omeprazole in the prevention of bleeding from esophageal ulcer after esophageal varices
Acronym
A study to evaluate the benefit of omeprazole in the prevention of bleeding from esophageal ulcer after esophageal varices
Scientific Title
A study to evaluate the benefit of omeprazole in the prevention of bleeding from esophageal ulcer after esophageal varices
Scientific Title:Acronym
A study to evaluate the benefit of omeprazole in the prevention of bleeding from esophageal ulcer after esophageal varices
Region
| Japan |
Condition
Condition
Patients with esophageal ulcer (no less than 20 years old)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of omepazole to that of famotidine in the prevention of bleeding from esophageal ulcer after the procedure including the latest endoscopic therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ulcer healing rate, Esophagostenosis, GOS score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
omeprazol
Interventions/Control_2
famotidine
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with esophageal ulcer
Key exclusion criteria
1) Patients with previous partial gastrectomy or vagotomy
2) Patients with sever cerebral, cardiac, renal, or hematopoietic dysfunction
3) Patients with contraindications to any test drugs
4) Pregnant or lactating women or women who plan to become pregnant during the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Araki |
Organization
Gifu University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-1 Yanagido,Gifu,Gifu 501-1112
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu University Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Research fund of The Gifu University Hospital,Department of Endoscopy
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
| 2011 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
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
| 2011 | Year | 06 | Month | 10 | Day |
Last modified on
| 2011 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006786
