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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013103
Receipt No. R000015288
Scientific Title The safety and efficacy of a new bowel preparation for colonoscopy
Date of disclosure of the study information 2014/02/07
Last modified on 2016/08/04

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Basic information
Public title The safety and efficacy of a new bowel preparation for colonoscopy
Acronym The safety and efficacy of a new bowel preparation for colonoscopy
Scientific Title The safety and efficacy of a new bowel preparation for colonoscopy
Scientific Title:Acronym 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
1st name
Middle name
Last name HIro-o Yamano
Organization Akita Red Cross Hospital
Division name Division of Gastroenterology
Zip code
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
1st name
Middle name
Last name HIro-o Yamano
Organization Akita Red Cross Hospital
Division name Division of Gastroenterology
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 12 Month 20 Day
Date of IRB
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

Other
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

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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