UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011641 |
|---|---|
| Receipt number | R000013607 |
| Scientific Title | Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription |
| Date of disclosure of the study information | 2013/09/05 |
| Last modified on | 2015/01/11 22:27:18 |
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Basic information
Public title
Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription
Acronym
reflux esophagitis, PPI treatment and magnification and ultra-magnification endoscopy
Scientific Title
Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription
Scientific Title:Acronym
reflux esophagitis, PPI treatment and magnification and ultra-magnification endoscopy
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate magnification and ultra-magnification endoscopic findings before and after administration of esomeprazole with special reference to inflammatory cell infiltration
Basic objectives2
Others
Basic objectives -Others
to evaluate the relationship between histopathological and immunohistochemical appearances and magnification and ultramagnification endoscopic findings
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
magnification and ultra-magnification endoscopic findings in reflux esophagitis before and after esomeprazole treatment
Key secondary outcomes
alteration in magnification and ultra-magnification endoscopic findings before and after esomeprazole treatment
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of 20mg of esomeprazole for 8 weeks
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
over 20 years old
PS(ECOG) 0 or 1
more than WBC, 3,000/mm3; Hb, 8.0g/d; Plt, 75,000/mm3; AST, 100IU/L; ALT, 100IU/L; T-bil, 2.0mg/dL; sCr, 2.0mg/dL
written informed consent
Key exclusion criteria
without cormobid severe diseases including heart, kidney and liver failure
during pregnancy and/or milk feeding
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
hhisomot@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime isomoto |
Organization
Nagasaki University Hospital
Division name
Endoscopy
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7336
Homepage URL
hhisomot@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneka
Organization
Division
Category of Funding Organization
Profit organization
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 | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | 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
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2015 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013607
