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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001566
Receipt No. R000001859
Scientific Title A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing.
Date of disclosure of the study information 2008/12/11
Last modified on 2016/02/18

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Basic information
Public title A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing.
Acronym A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing.
Scientific Title A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing.
Scientific Title:Acronym A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing.
Region
Japan

Condition
Condition Colonic disorder
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the patient acceptance of sodium phosphate tablet With 2L polyethylene glycol solution plus sodium picosulfate solution for colon cleansing by cross over design.
Basic objectives2 Others
Basic objectives -Others Quality of colon clensing and Frequency of adverse event(abdominalpain,nausea,bloating etc.)
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes patient acceptance
Key secondary outcomes Quality of colon clensing and Frequency of adverse event(abdominalpain,nausea,bloating etc.)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 GroupA: 2L Polyethylene glycol solution plus Sodium picosulfate solution for first time colonoscopy and Sodium Phosphate Tablet for for second time colonoscopy.
Interventions/Control_2 GroupB: Sodium Phosphate Tablet for first time colonoscopy and 2L Polyethylene glycol solution plus Sodium picosulfate solution for for second time colonoscopy.
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 Patient who require colonoscpy two or more times within one year.
Key exclusion criteria 1.Patient who have contraindication to NaP tablet and PEG solution.
2.Patient who is in active stage of inflammatory bowel disease.
3.Patient who have dysphagia.
4.Patient who is after colonic operation.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hosenao@db3.so-net.ne.jp

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department

Funding Source
Organization Division of Gastroenterology,Department of Internal Medicine, Keio University
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
2008 Year 12 Month 11 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 Hosoe N, et al. Comparison of patient acceptance of sodium phosphate versus polyethylene glycol plus sodium picosulfate for colon cleansing in Japanese. J Gastroenterol Hepatol. 2012 Oct;27(10):1617-22.
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
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 11 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001859

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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