UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037297
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ishibashi@tsurukamekai.jp

Sponsor
Institute Shinjuku Tsurukame Clinic, Digestive Disease Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.