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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011269
Receipt No. R000013208
Scientific Title The efficacy of novel preparation liquid as bowel preparation for colonoscopy
Date of disclosure of the study information 2013/07/31
Last modified on 2018/09/05

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Basic information
Public title The efficacy of novel preparation liquid as bowel preparation for colonoscopy
Acronym The analysis of bowel preparation for colonoscopy
Scientific Title The efficacy of novel preparation liquid as bowel preparation for colonoscopy
Scientific Title:Acronym The analysis of bowel preparation for colonoscopy
Region
Japan

Condition
Condition colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the efficacy of Moviprep with special diet and laxative
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cleasing grade of preparations and patient's acceptability and complication
Key secondary outcomes the safeness for cases with renal dysfunction and elderly people

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 taking Moviprep
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients schduling colonoscopic examination
2. Patients taking other bowel preparation previously
3. performance status 0-2
Key exclusion criteria patients with severe main organ's disorder
Target sample size 10000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Email naohisa@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Homepage URL
Email naohisa@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of medicine
Institute
Department

Funding Source
Organization Department of Molecular Gastroenterology, Kyoto Prefectural University of medicine
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
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
2013 Year 07 Month 31 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
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 04 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 24 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013208

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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