UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008271 |
|---|---|
| Receipt number | R000009683 |
| Scientific Title | The trial to set a suitable period of using esomeprazole to cure the gastric ulcer after endoscopic submucosal dissection (ESD) for mucosal cancers of the stomach. |
| Date of disclosure of the study information | 2012/06/27 |
| Last modified on | 2015/04/08 18:51:08 |
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Basic information
Public title
The trial to set a suitable period of using esomeprazole to cure the gastric ulcer after endoscopic submucosal dissection (ESD) for mucosal cancers of the stomach.
Acronym
The trial to set a suitable period of using esomeprazole to cure the gastric ulcer after endoscopic submucosal disssection (ESD) for mucosal cancers of the stomach.
Scientific Title
The trial to set a suitable period of using esomeprazole to cure the gastric ulcer after endoscopic submucosal dissection (ESD) for mucosal cancers of the stomach.
Scientific Title:Acronym
The trial to set a suitable period of using esomeprazole to cure the gastric ulcer after endoscopic submucosal disssection (ESD) for mucosal cancers of the stomach.
Region
| Japan |
Condition
Condition
mucosal cancer of the stomach
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To certify a suitable period of using esomeprazole to cure the gastric ulcers of the ESD for mucosal cancers of the stomach.
Basic objectives2
Others
Basic objectives -Others
The biological trend after medical treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A period to cure the ESD ulcer in the stomach.
Key secondary outcomes
A period required to cure the ESD ulcer relative to its location and size, respectively.
A rate of the ulcer healing at the time of 4 weeks, 6 weeks, and 8 weeks after ESD, respectively.
A rate of the ulcer shrinkage at the time of 4 weeks, 6 weeks, and 8 weeks after ESD, respectively.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 resected the mucosal cancer of the stomack by endoscopic submucosal resection (ESD).
Key exclusion criteria
1)Hypersensitivity of Esomeprazole
2)Taking the medicine which is prohibited to take together with Esomeprazole
3)Under pregnancy or breast-feeding
4)Impossibility of oral intake
5)Past history of resection of upper GI
6)Taking medicines which are possible to interact with Esomeprazole
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahimachi, Machida-shi, Tokyo
TEL
042-722-2230
m.izumi@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Uchida |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahimachi, Machida-shi, Tokyo
TEL
042-722-2230
Homepage URL
eri_uchida0713@yahoo.co.jp
Sponsor or person
Institute
Machida municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Machida municipal hospital
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 27 | 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
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009683
