UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001566 |
|---|---|
| Receipt number | 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 19:30:44 |
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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
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
hosenao@db3.so-net.ne.jp
Sponsor or person
Institute
Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001859
