UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006321 |
|---|---|
| Receipt number | R000007493 |
| Scientific Title | Feasibility study to evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution. |
| Date of disclosure of the study information | 2011/09/10 |
| Last modified on | 2015/12/03 13:37:33 |
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Basic information
Public title
Feasibility study to evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution.
Acronym
Feasibility study to evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution.
Scientific Title
Feasibility study to evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution.
Scientific Title:Acronym
Feasibility study to evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution.
Region
| Japan |
Condition
Condition
Colonic disorder
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficucy of colon cleansing regimen: low fiber diet plus low volume Polyethylene Glycol Solution with Sodium Picosulfate Solution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel cleansing level
Key secondary outcomes
Patient's acceptance, Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low fiber diet plus 1L of PEG with Sodium picosulfate solution for colon cleansing
Interventions/Control_2
2L of PEG with Sodium picosulfate solution for colon cleansing
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 hwve a experience ofcolonoscopy.
Key exclusion criteria
1.Patient who have contraindication to 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
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe |
Organization
Keio University
Division name
Centrer for diagnostic therapeutic Endoscopy
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 | Naoi Hosoe |
Organization
Keio University
Division name
Centrer for diagnostic therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Centrer for diagnostic therapeutic Endoscopy, Keio university
Institute
Department
Personal name
Funding Source
Organization
Centrer for diagnostic therapeutic Endoscopy, 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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 10 | 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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 09 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007493
