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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011915
Receipt No. 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

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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
Email 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
Email m1156849@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013916

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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