UMIN-CTR Clinical Trial

Basic information
Public title	A markedly reduced-laxative CT colonography: a radormized clinical trial
Acronym	Reduced-laxative CTC Study
Scientific Title	A markedly reduced-laxative CT colonography: a radormized clinical trial
Scientific Title:Acronym	Reduced-laxative CTC Study
Region	Japan

Condition
Condition	colorectal disease
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate an optimal dose of MoviPrep for reduced-laxative CT colonography
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Quality of bowel preparation for CT colonography (size of residual feces, volume of residual liquid, quality of fecal tagging)
Key secondary outcomes	patient acceptability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	total dose of MoviPrep 400ml
Interventions/Control_2	total dose of MoviPrep 600ml
Interventions/Control_3	total dose of MoviPrep 800ml
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients suspicious for colorectal diseases, who need colon screening test
Key exclusion criteria	Inflammatory bowel disease, familial adenomatous polyposis, Lynch syndrome, history of bowel resection, GI tract stenosis obstruction or perforation, toxic megacolon. High risk for bowel preparation or CT colonography, pregnancy or its possibility, psychiatric disease or symptom, claustrophobia, serious iodine allergy, thyroidal disease, and others
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenichi Utano
Organization	Fukushima Medical University
Division name	Aizu Medical Center
Zip code
Address	Aizuwakamatsu-city, Fukushima
TEL	+81-242752100
Email	k-utano@fmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenichi Utano
Organization	Fukushima Medical University
Division name	Aizu Medical Center
Zip code
Address	Aizuwakamatsu-city, Fukushima
TEL	+81-242752100
Homepage URL
Email	k-utano@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	EA pharma
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
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	福島県立医科大学会津医療センター附属病院（福島県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 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
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	2016 Year 05 Month 31 Day
Date of IRB	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date	2019 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 23 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026325

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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