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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008161
Receipt No. R000009610
Scientific Title The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Date of disclosure of the study information 2012/06/13
Last modified on 2019/07/18

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Basic information
Public title The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Acronym The combined therapy with proton pump inhibitor and irsogladine for post-ESD gastric ulcer
Scientific Title The study for the efficacy of the combine therapy with proton pump inhibitor and irsogladine for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Scientific Title:Acronym The combined therapy with proton pump inhibitor and irsogladine for post-ESD gastric ulcer
Region
Japan

Condition
Condition Gastric ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of the combined therapy with proton pump inhibitor and irsogladine for the artificial gastric ulcer after endoscopic submucosal dissection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cure rates of gastric ulcer at 4 and 8 weeks of the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rabeprazole 10mg/day for 8 weeks p.o.
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 Patients over the age of 20 with gastric adenoma or early cancer who were referred to our hospital for the purpose of ESD
Key exclusion criteria 1)Patients with repeated bleeding
2)major organ failure (such as cardiac and
pulmonary complications)
3)Those with drug allergy
4)Concomitant administration of anticoagulants and antiinflammatory
drugs
5)Patients with residual cancer histologically
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65,Tsurumai-cho,Showa-ku,Nagoya 466-8560
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65,Tsurumai-cho,Showa-ku,Nagoya 466-8560
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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
2012 Year 06 Month 13 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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
2012 Year 06 Month 13 Day
Last modified on
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009610

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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