UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006951 |
|---|---|
| Receipt number | R000008209 |
| Scientific Title | The investigation for the period of proton pump inhibitor for gastric ulcer after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2013/12/26 09:51:28 |
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Basic information
Public title
The investigation for the period of proton pump inhibitor for gastric ulcer after endoscopic submucosal dissection
Acronym
The investigation for the period of PPI for gastric ulcer after ESD
Scientific Title
The investigation for the period of proton pump inhibitor for gastric ulcer after endoscopic submucosal dissection
Scientific Title:Acronym
The investigation for the period of PPI for gastric ulcer after ESD
Region
| Japan |
Condition
Condition
patients with gastric cancer or adenoma who underwent ESD
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of 2 weeks of PPI administration compared to 4 weeks on reduction in area of gastric ulcer after ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction rate in area of gastric ulcer after ESD
Key secondary outcomes
QOL (GSRS) at 4 weeks after ESD
Relation between GSRS and reduction rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
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
esomeprazole 20mg per day for 4 weeks
Interventions/Control_2
esomeprazole 20mg per day for 2 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 with gastric cancer or adenoma who underwent ESD
Key exclusion criteria
(1) patients with gastrectomy during treatment
(2) patients who are pregnant or nursing
(3) patients with severe liver or renal dysfunction
(4) patients with use of anti-thrombosis drug
(5) patients wit bleeding tendency
(6) drug allergy for esomeprazole
(7) patients who are diagnosed as unsuitable for this trial by investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL
043-226-2083
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
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
千葉大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 26 | 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
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008209
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| Registered date | File name |
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