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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032377
Receipt No. R000034828
Scientific Title Esophageal motility disorders caused by esophageal eosinophilia
Date of disclosure of the study information 2019/03/31
Last modified on 2018/04/25

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Basic information
Public title Esophageal motility disorders caused by esophageal eosinophilia
Acronym Esophageal motility disorders by eosinophil infiltration
Scientific Title Esophageal motility disorders caused by esophageal eosinophilia
Scientific Title:Acronym Esophageal motility disorders by eosinophil infiltration
Region
Japan

Condition
Condition Esophageal motility disorders
Eosinophilic esophagitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the esophageal motility in the patients with eosinophilic esophagitis , the impact of eosinophil infiltration on primary esophageal motility disorders, thus we will find the useful knowledge for the strategy to choose the best treatment for the patients with esophageal motility disorders
Basic objectives2 Others
Basic objectives -Others Pathophysiological investigation
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of esophageal motility disorders in the patients with eosinophilic infiltration into esophageal mucosa
Key secondary outcomes The prevalence of eosinophil infiltration among eosinophilic esophagitis

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent both esophageal manometry and endoscopic biopsy to determine eosinophil infiltration in esophageal mucosa
Key exclusion criteria None
Target sample size 306

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Uraoka
Organization Gunma University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma
TEL 0027-220-8137
Email uraoka@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Hosaka
Organization Gunma University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma
TEL 027-220-8137
Homepage URL
Email hhosaka@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization None
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
Email

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 群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Unpublished

Management information
Registered date
2018 Year 04 Month 25 Day
Last modified on
2018 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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