UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy of a new bowel preparation for colonoscopy
Title of the study (Brief title)	The safety and efficacy of a new bowel preparation for colonoscopy
Region	Japan

Condition
Condition	candidate for colonoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the saftey of Niflec, moviprep(Mov) and fractionated MOV for Bowel Preparation before colonoscopy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Efficacy and Patient's Acceptance and Tolerability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Bowel preparation using Niflec for colonoscopy
Interventions/Control_2	Bowel preparation using Moviprep for colonoscopy
Interventions/Control_3	Bowel preparation using fractionated Moviprep for colonoscopy
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	Person in need of colonoscopy
Key exclusion criteria	1)Patients with acute or chronic kidney failure (Cre>1.5mg/dL) 2)Patients with heart failure (NYHA class III or IV) 3)Patients performed bypass surgery or with endovascular treatment or myocardial infarction within 3 month's 4)Patients with hyponatremia, hypokalemia or hyperphosphatemia 5)Patients with chronic IBD during an acute exacerbation 6)Patients with a history of gastrointestinal tractresection (excluding appendicectomy) 7)Patients who may have ileus or failure of gastric empty 8)Patients who has perforation and may have perforation of gastrointestinal tract 9)Patients with toxic megacolon 10)In colonoscopy, patients who have a history of colonic diverticula or colonic narrowing with clinical symptoms 11)Patients with severe constipation(<3 times a week of bowel movement for more than a year) 12)Patients with a history of severe drug allergy 13)Women who are pregnant, breast-feeding or likely to be pregnant 14)Patients with advanced colorectal cancer 15)Person who is difficult to get propriety judgment of participation 16)Patients who are considered to be unsuitable by the trial investigators
Target sample size	300

Research contact person
Name of lead principal investigator	HIro-o Yamano
Organization	Akita Red Cross Hospital
Division name	Division of Gastroenterology
Address	222-1 Nawashirosawa, Saruta Kamikitade, Akita, JAPAN
TEL	018-829-5000
Email	h-yamano@h9.dion.ne.jp

Public contact
Name of contact person	HIro-o Yamano
Organization	Akita Red Cross Hospital
Division name	Division of Gastroenterology
Address	222-1 Nawashirosawa, Saruta Kamikitade, Akita, JAPAN
TEL	018-829-5000
Homepage URL
Email	h-yamano@h9.dion.ne.jp

Sponsor
Institute	Akita Red Cross Hospital
Institute
Department

Funding Source
Organization	Ajinomoto Pharmaceuticals Co. Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2013 Year 12 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 07 Day
Last modified on	2016 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015288