UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014157 |
|---|---|
| Receipt number | R000016440 |
| Scientific Title | A Nationwide Study of Esophageal Bleeding and Strictures Caused by Reflux Esophagitis |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/02/20 16:52:52 |
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Basic information
Public title
A Nationwide Study of Esophageal Bleeding and Strictures Caused by Reflux Esophagitis
Acronym
Study for the COmplication of Reflux Esophagitis (SCORE)
Scientific Title
A Nationwide Study of Esophageal Bleeding and Strictures Caused by Reflux Esophagitis
Scientific Title:Acronym
Study for the COmplication of Reflux Esophagitis (SCORE)
Region
| Japan |
Condition
Condition
Reflux esophagitis (RE)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this nationwide, multicenter study is to identify and characterize cases of esophageal bleeding and strictures (including lumen deformation) caused by RE.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics of RE patients with RE-induced bleeding or strictures (deformation).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical characteristics of RE patients with RE-induced bleeding or strictures (deformation).
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with LA Grade A or greater RE confirmed during the study period by upper gastrointestinal endoscopy performed for a reason unrelated to a health examination.
(2) Outpatient or hospitalized men and women at least 50 years of age.
(3) Patients who have personally or via a legally acceptable representative given written consent.
Key exclusion criteria
(1) Patients with RE occurring subsequent to upper gastrointestinal tract resection, endoscopic treatment of the upper gastrointestinal tract, or gastrostomy.
(2) Patients whom the investigators find ineligible for participation in the study for any reason.
Target sample size
5300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Haruma |
Organization
Kawasaki Medical School
Division name
Division of Gastroenterology
Zip code
Address
577, Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
kharuma@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
Address
577, Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
n_manabe@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Society for GERD
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
| 2014 | Year | 10 | Month | 01 | 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
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical characteristics of RE patients with RE-induced bleeding or strictures (deformation).
Management information
Registered date
| 2014 | Year | 06 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016440
