UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011979 |
|---|---|
| Receipt number | R000013994 |
| Scientific Title | Clinical utility of pre-package 2 meal products low-residue diet on bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2015/09/28 18:30:00 |
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Basic information
Public title
Clinical utility of pre-package 2 meal products low-residue diet on bowel preparation for colonoscopy
Acronym
Clinical utility of low-residue diet on bowel preparation for colonoscopy
Scientific Title
Clinical utility of pre-package 2 meal products low-residue diet on bowel preparation for colonoscopy
Scientific Title:Acronym
Clinical utility of low-residue diet on bowel preparation for colonoscopy
Region
| Japan |
Condition
Condition
Patients who underwent colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether pre-package 2 meal products can allow for a reduced dose of bowel preparation solution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The dose of bowel preparation requid.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
pre-package 2 meal products low-residue diet
Interventions/Control_2
low-residue diet
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
Patients who underwent colonoscopy
Key exclusion criteria
Patients with constipation, inflamatory bowel disease, diabetes melitus, or those who underwent colectomy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Matsumura |
Organization
Chiba University
Division name
Department of Endoscopic Diagnostics and Therapeutics, Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2329
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Matsumura |
Organization
Chiba University
Division name
Department of Endoscopic Diagnostics and Therapeutics, Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2329
Homepage URL
matsumura@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Kaigen Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 10 | Month | 10 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013994
