UMIN-CTR Clinical Trial

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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