UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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 &#8805; 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	Francis KL Chan
Organization	Chinese University of Hong Kong
Division name	Faculty of Medicine
Address	Prince of Wales Hospital, Shatin, N.T., Hong Kong
TEL	0666453811
Email

Public contact
Name of contact person	Tetsuya Tanigawa
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address
TEL
Homepage URL
Email	ttanigawa@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012954