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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001069
Receipt No. R000001238
Scientific Title Effect of an H2 receptor antagonist or a proton pump inhibitor on prevention of bleeding and healing of the endoscopic submucosal dissection-induced ulceration :a prospective randomized controlled trial
Date of disclosure of the study information 2008/03/10
Last modified on 2015/12/03

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Basic information
Public title Effect of an H2 receptor antagonist or a proton pump inhibitor on prevention of bleeding and healing of the endoscopic submucosal dissection-induced ulceration :a prospective randomized controlled trial
Acronym Effect of an H2 receptor antagonist or a proton pump inhibitor on prevention of bleeding and healing of the endoscopic submucosal dissection-induced ulceration :a prospective randomized controlled trial
Scientific Title Effect of an H2 receptor antagonist or a proton pump inhibitor on prevention of bleeding and healing of the endoscopic submucosal dissection-induced ulceration :a prospective randomized controlled trial
Scientific Title:Acronym Effect of an H2 receptor antagonist or a proton pump inhibitor on prevention of bleeding and healing of the endoscopic submucosal dissection-induced ulceration :a prospective randomized controlled trial
Region
Japan

Condition
Condition early gastric cancer,gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness of H2RA(Roxatidine acetate hydrochloride) with PPI (Lansoprazole) for ESD-induced ulcer against early gastric cancer or gastric adenoma on prevention of bleeding and healing ratio.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Bleeding and healing rario after ESD.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of H2RA(Roxatidine acetate hydrochloride) for ESD-induced ulcer
Interventions/Control_2 Administration of PPI (Lansoprazole) for ESD-induced ulcer
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 Patients who were diagnosed as early gastric cancer or gastric adenoma and are considered as the indication of endoscopic submucosal dissection.
Key exclusion criteria Patients who have anticoagulant or antiplatelet therapy and who cannot stop it.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Imaeda, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hosenao@db3.so-net.ne.jp

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, Keio University
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
2008 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 07 Day
Last modified on
2015 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001238

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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