UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037297 |
|---|---|
| Receipt number | R000042520 |
| Scientific Title | Low-volume administration of polyethylene glycol laxative for bowel preparation |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2020/03/31 23:19:28 |
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Basic information
Public title
Low-volume administration of polyethylene glycol laxative for bowel preparation
Acronym
Low-volume administration of polyethylene glycol laxative for bowel preparation
Scientific Title
Low-volume administration of polyethylene glycol laxative for bowel preparation
Scientific Title:Acronym
Low-volume administration of polyethylene glycol laxative for bowel preparation
Region
| Japan |
Condition
Condition
suspicious of colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of small-volume polyethylene glycol laxative for bowel preparation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration time for bowel preparation on the examination day, the level of bowel preparation, and adenoma detection rate on the examination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Conventional preparation group (Sennna 1g, 3 days)
Interventions/Control_2
Novel preparation group (Polyethylene glycol 13.7g, 3 days)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From August, 2019 to January, 2020.
Outpatients who receive screening colonoscopy in the institution.
Key exclusion criteria
Patients who received surgical resection of the colon, suffered from inflammatory bowel disease and receive treatment for chronic constipation.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
Koganei Tsurukame Clinic
Division name
Endoscopy center
Zip code
184-0004
Address
6-14-28, Honcho, Koganei-shi, Tokyo
TEL
042-386-3757
ishibashi@tsurukamekai.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
Koganei Tsurukame Clinic
Division name
Endoscopy center
Zip code
184-0004
Address
6-14-28, Honcho, Koganei-shi, Tokyo
TEL
042-386-3757
Homepage URL
ishibashi@tsurukamekai.jp
Sponsor or person
Institute
Shinjuku Tsurukame Clinic, Digestive Disease Center
Institute
Department
Personal name
Funding Source
Organization
Shinjuku Tsurukame Clinic, Digestive Disease Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinjuku Tsurukame Clinic
Address
2-11-15-3F, Yoyogi, Shibuya-ku, Tokyo
Tel
03-3299-0077
ishibashi@tsurukamekai.jp
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
| 2019 | Year | 08 | Month | 01 | 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
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042520
