UMIN-CTR Clinical Trial

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

Contact us.