UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011915 |
|---|---|
| Receipt number | R000013916 |
| Scientific Title | Proton pump inhibitor versus histamine-2 receptor antagonist for prevention of bleeding after ESD in patients on low-dose aspirin therapy (PH-BEST study) |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2013/09/30 18:32:47 |
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Basic information
Public title
Proton pump inhibitor versus histamine-2 receptor antagonist for prevention of bleeding after ESD in patients on low-dose aspirin therapy (PH-BEST study)
Acronym
PH-BEST study
Scientific Title
Proton pump inhibitor versus histamine-2 receptor antagonist for prevention of bleeding after ESD in patients on low-dose aspirin therapy (PH-BEST study)
Scientific Title:Acronym
PH-BEST study
Region
| Japan |
Condition
Condition
Patients with gastric adenoma or early gastric cancer receiving low-dose aspirin
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy between rabeprazole and famotidine on post-ESD ulcer bleeding and healing of ESD-induced ulcers in patients on low-dose aspirin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of post-ESD ulcer bleeding
Key secondary outcomes
Healing rate of ulcers at 8 weeks after ESD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole sodium
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients of 20 years or elder
2. Patients taking LDA more than 4 weeks
3. Patients with high risk of thrombosis
4. Patients who are recommended taking LDA by thier doctor or specialist
5. Patients who will take LDA at least 8 weeks
6. Patients with gastric lesion which can be resected by en-bloc fashion
7. Patients with gastric adenoma or early gastric cancer which correspond to standard indication or expanded indication
8. Patients with performance status 0 to 2
Key exclusion criteria
1. Patients with allergy for rabeprazole and famotidine
2. Patients taking anticoagulants
3. Patients with active peptic ulcer
4. Patients on dialysis
5. Patients under treatment of atazanavir sulfate
6. Patients who have other malignant neoplasms or serious disease
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Watanabe |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku,Osaka
TEL
06-6645-3811
watanabet@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusei Fukunaga |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku,Osaka
TEL
06-6645-3811
Homepage URL
m1156849@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 20 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2013 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013916
