UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Acronym	The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Scientific Title	The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Scientific Title:Acronym	The usefulness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefluness of Colon Capsule Endoscopy for patients with ulcerative colitis.
Basic objectives2	Others
Basic objectives -Others	We research relation between the passage time of Colon Capsule Endoscopy and the activity of Ulcerative colitis.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	evaluation of the mucosa in colon
Key secondary outcomes	passage time

Base
Study type	Others,meta-analysis etc

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patients with active ulcerative colitis
Key exclusion criteria	1) The patients with a history of the operation of the bowels 2) Pregnant or breast feeding women and women suspected of being pregnant 3) The patients of the severe constipation 4) The patients with the history of the ileus 5) The patients who needs monitoring 6) The patients are severe or fulminant in clinical activity of ulcerative colitis 7) The patients judged as inadequate for this study by attending physician
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Fumiaki Middle name Last name Takahashi
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282-87-2147
Email	tfumi@dokkyomed.ac.jp

Public contact
1st name of contact person	1st name Fumiaki Middle name Last name Takahashi
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282-87-2147
Homepage URL
Email	tfumi@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
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	Dokkyo Medical University
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel	0282-86-1111
Email	tfumi@dokkyomed.ac.jp

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 05 Month 01 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	20
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	Terminated
Date of protocol fixation	2014 Year 03 Month 11 Day
Date of IRB	2014 Year 03 Month 11 Day
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Examination cancellation

Management information
Registered date	2014 Year 04 Month 24 Day
Last modified on	2019 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015978