UMIN-CTR Clinical Trial

Basic information
Public title	The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD -multicenter randomized controlled study of irsogladine + PPI versus PPI alone-
Acronym	The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
Scientific Title	The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD -multicenter randomized controlled study of irsogladine + PPI versus PPI alone-
Scientific Title:Acronym	The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD
Region	Japan

Condition
Condition	gastric tumor(early gastric cancer, gastric adenoma)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy of combined therapy with irsogladine and PPI for the patients with early gastric cancer or gastric adenoma during treatment of antithrombotic drugs after ESD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Frequency of gastrointestinal bleeding after ESD
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rabeprazole 10mg/day p.o. for 8 weeks
Interventions/Control_2	rabeprazole 10mg/day and irsogladine 4mg/day p.o. for 8 weeks
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	Subjects with gastric tumor who are aged 20 years or older when the written informed consent is obtained
Key exclusion criteria	1)Subjects with hematemesis, melena or anemia lack of hemoglobin 2 g/dL or more during the observation period 2)Subjects with significant hepatic disease, renal disease, heart disease or respiratory disease 3)Subjects with a history of gastrointestinal surgery other than appendectomy 4)Subjects orally taking or planning to orally take drug other than rabeprazole or irsogladine 5)Pregnancy or lactation 6)Subjects whom otherwise the investigator determined ineligible as the subject
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhide Higuchi
Organization	Osamka Medical Collage
Division name	Department of Internal Medicine
Zip code
Address	2-7 Daigakumachi, Takatsuki, Osaka
TEL	072-683-1221
Email	higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshihisa Takeuchi
Organization	Osaka Medical College Hospital
Division name	Endoscopic Center
Zip code
Address	2-7 Daigakumachi, Takatsuki, Osaka
TEL	072-683-1221
Homepage URL
Email	in2097@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	None
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
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

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 28 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	Completed
Date of protocol fixation	2013 Year 11 Month 27 Day
Date of IRB	2013 Year 11 Month 10 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2015 Year 07 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 28 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014548

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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