UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009367 |
|---|---|
| Receipt number | R000011007 |
| Scientific Title | A prospective trial of esomeprazole effect on the healing process of post-gastric endscopic submucosal dissection (ESD) ulcers |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2017/05/25 12:11:36 |
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Basic information
Public title
A prospective trial of esomeprazole effect on the healing process of post-gastric endscopic submucosal dissection (ESD) ulcers
Acronym
efficacy of esomeprazole for post-ESD ulcers
Scientific Title
A prospective trial of esomeprazole effect on the healing process of post-gastric endscopic submucosal dissection (ESD) ulcers
Scientific Title:Acronym
efficacy of esomeprazole for post-ESD ulcers
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the healing rate of post ESD ulcers in response to the esomeprazole(20mg/day) treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the healing rates of post-ESD ulcers at 4, 8 weeks after ESD
Key secondary outcomes
the rate of post-ESD bleeding with emergent endoscopy
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 will undergo ESD for gastric neoplasms at Tsuchiura kyodo hospital
Key exclusion criteria
1)Patients who are pregnant or nursing
2)Drug allergy for esomeprazole
3)Patients who are diagnosed as unsuitable for this trial by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ichida |
Organization
Tsuchiura kyodo hospital
Division name
Division of gastroenterology
Zip code
Address
11-7, Manabeshinmachi, Tsuchiura City, Japan
TEL
0298303711
taka_taka0621@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ichida |
Organization
Tsuchiura kyodo hospital
Division name
Division of gastroenterology
Zip code
Address
11-7, Manabeshinmachi, Tsuchiura City, Japan
TEL
029-823-3111
Homepage URL
taka_taka_0621@yahoo.co.jp
Sponsor or person
Institute
Tsuchiura kyodo hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuchiura kyodo 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
| 2013 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2012 | Year | 11 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011007
