UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection
Title of the study (Brief title)	MOVI STUDY
Region	Japan

Condition
Condition	Colorectal tumor
Classification by specialty	Gastroenterology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of Moviprep (low-volume colonoscopy prep) and Muben (standard-volume) on the bowel preparation for the patients undergo colorectal endoscopic submucosal dissection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Preparation time
Key secondary outcomes	Boston Bowel Preparation Scale score, acceptability, taste, frequencies of stool, total volume of the prep, complication rate.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Moviprep 1.5L ~ 2L
Interventions/Control_2	Muben 3L ~ 4L
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent colorectal endoscopic submucosal dissection (ESD) at National Cancer Center Hospital. 1. Indication for colorectal ESD 2. Irrespective of number of the lesion 3. Age from 20 years old to 75 years old 4. Performance status 0, 1, 2 5. Patients who has written informed consent for this study
Key exclusion criteria	1. Patients having risk of perforation, obstruction and suspicious of ileum. 2. Toxic megacolon 3. Allergy for Moviprep and Muben 4. Dehydration 5. Mental disease 6. Without written informed consent 7. Angina pectoris and/or past history of myocardial infarction within 6 months. 8. Active inflammatory bowel diseases 9. Past history of convulsive attack 10. Serum creatinine level &#8805;1.3 mg/dL 11. Others (depends on the chief physician)
Target sample size	100

Research contact person
Name of lead principal investigator	Takahisa Matsuda
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	+81-3-3542-2511
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	Masayoshi Yamada
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	+81-3-3542-2511
Homepage URL
Email	masyamad@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Ajinomoto Pharmaceuticals Co., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 20 Day
Anticipated trial start date	2014 Year 08 Month 15 Day
Last follow-up date	2015 Year 08 Month 15 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

Management information
Registered date	2014 Year 07 Month 28 Day
Last modified on	2017 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017061