UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011072 |
|---|---|
| Receipt number | R000012954 |
| Scientific Title | Histamine-2 Receptor Antagonist Versus Proton-Pump Inhibitor for the Prevention of Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk (ASP (PPI_H2RA) Study) |
| Date of disclosure of the study information | 2013/06/29 |
| Last modified on | 2017/05/11 15:33:31 |
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Basic information
Public title
Histamine-2 Receptor Antagonist Versus Proton-Pump Inhibitor for the Prevention of Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk (ASP (PPI_H2RA) Study)
Acronym
H2RA VS PPI for the Prevention of Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk
Scientific Title
Histamine-2 Receptor Antagonist Versus Proton-Pump Inhibitor for the Prevention of Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk (ASP (PPI_H2RA) Study)
Scientific Title:Acronym
H2RA VS PPI for the Prevention of Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk
Region
| Japan | Asia(except Japan) |
Condition
Condition
Ulcer Bleeding Associated With Low-dose Aspirin in Patients With Very High Ulcer Risk
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to test the hypothesis that PPI is superior to H2RA for the prevention of recurrent ulcer bleeding in ASA users with a history ulcer bleeding.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reccurent ulcer bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
famotidine 40 mg/day
Interventions/Control_2
rabeprazole 20 mg/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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable)
2. Negative tests for H. pylori or successful eradication of H. pylori based on urease test and histology
3. Expected regular use of ASA for the duration of the trial
4. Age ≥ 18
5. Written informed consent obtained
Key exclusion criteria
1. A history of gastric or duodenal surgery other than patch repair
2. Severe erosive esophagitis (LA grade C or D)
3. Gastric outlet obstruction
4. Terminal illness
5. Active malignancies
Target sample size
332
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Francis KL Chan |
Organization
Chinese University of Hong Kong
Division name
Faculty of Medicine
Zip code
Address
Prince of Wales Hospital, Shatin, N.T., Hong Kong
TEL
0666453811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Tanigawa |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
ttanigawa@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
YES
Study ID_1
NCT01408186
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪市立大学 消化器内科
香港大学 消化器内科
佐賀大学 内科学
大阪医科大学 第二内科
島根大学 第二内科 木下芳一
大阪市立総合医療センター 消化器内科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
| 2013 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012954
