UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the gastrointestinal disorder in patients with systemic sclerosis
Title of the study (Brief title)	Elucidation of the gastrointestinal disorder in patients with systemic sclerosis
Region	Japan

Condition
Condition	Systemic sclerosis Gastroesophageal Reflux disease
Classification by specialty	Medicine in general Gastroenterology Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our aim is to elucidate gastrointestinal disorder in patients with systemic sclerosis in Japan
Basic objectives2	Others
Basic objectives -Others	etiological influences
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence and grades of GERD in patients with systemic sclerosis
Key secondary outcomes	Identification of various background factors affecting the GERD in patients with systemic sclerosis

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	The study population was the subjects who received upper endoscopy at the department of gastroenterology, graduate school of medicine, the University of Tokyo and approved their entry to our study, were not less than 20 years old, and answered to the questionnaire
Key exclusion criteria	the subjects who are under 20 years old the subjects who have dementia the subjects who have emergency endoscopy by bleeding
Target sample size	250

Research contact person
Name of lead principal investigator	Nobutake Yamamichi
Organization	Graduate school of Medicine, the University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3815-5411
Email	nyamamic-tky@umin.ac.jp

Public contact
Name of contact person	Rie Matsuda
Organization	Graduate school of Medicine, the University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-3815-5411
Homepage URL
Email	matsuda-ktz@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology, the University of Tokyo
Institute
Department

Funding Source
Organization	Department of Gastroenterology, the University of Tokyo
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Dermatology, Faculty of Medicine, University of Tokyo
Name of secondary funｄer(s)

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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 30 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2017 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	All study participants data are accumulated

Management information
Registered date	2014 Year 04 Month 28 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016139