UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005429 |
|---|---|
| Receipt number | 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 00:39:58 |
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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
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
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006447
