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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005429
Receipt No. R000006447
Scientific Title Comparison of PPI with H2RA plus egualen sodium combination therapy for the artificial ulcer after ESD
Date of disclosure of the study information 2011/04/13
Last modified on 2011/04/13

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Basic information
Public title Comparison of PPI with H2RA plus egualen sodium combination therapy for the artificial ulcer after ESD
Acronym Comparison of PPI with H2RA plus egualen sodium combination therapy for the artificial ulcer after ESD
Scientific Title Comparison of PPI with H2RA plus egualen sodium combination therapy for the artificial ulcer after ESD
Scientific Title:Acronym Comparison of PPI with H2RA plus egualen sodium combination therapy for the artificial ulcer after ESD
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+egualen sodium with PPI for ESD-induced ulcer against early gastric cancer or gastric adenoma on healing ratio.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopic evaluations:The primary endopoint is the ulcer healing at 8 weeks after ESD.
Key secondary outcomes Endoscopic evaluations:ulcer healing rate
Symptom

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of H2RA(Famotidine)+ egualen sodium 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 1)Patients who have anticoagulant or antiplatelet therapy
2)Patients who had total gastrectomy during the course observation.
3)Women during pregnancy or breast-feeding.
4)Patients who have sever liver, renal disease,
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Kobayashi
Organization Kagawa University
Division name Department of gastroenterology and Neurology
Zip code
Address 1750-1 Miki Kida Kagawa Japan
TEL 087-891-2156
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa University
Division name Department of gastroenterology and Neurology
Zip code
Address
TEL 087-891-2156
Homepage URL
Email

Sponsor
Institute Kagawa university
Institute
Department

Funding Source
Organization Kagawa university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kagawa Rosai Hospital
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
2011 Year 04 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 Enrolling by invitation
Date of protocol fixation
2010 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2011 Year 04 Month 13 Day
Last modified on
2011 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006447

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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