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 UMIN000023895
Receipt No. R000027412
Scientific Title A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Date of disclosure of the study information 2016/10/01
Last modified on 2019/03/21

* 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 A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Acronym Split-dose vs morning-only dose preparation for afternoon colonoscopy
Scientific Title A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Scientific Title:Acronym Split-dose vs morning-only dose preparation for afternoon colonoscopy
Region
Japan

Condition
Condition Inpatient who have a plan to be performed colonoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the efficacy of the standard regimen compared to the alternate one; repeat to take 500 ml of PEG-ASC after 250 clear liquid three times.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was successful bowel cleansing.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 The standard regimen of PEG-ASC for afternoon colonoscopy in Japan is to take the first liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid, and to take 500 ml of PEG-ASC after 250 ml of clear water from 9 AM.
Interventions/Control_2 The split dose regimen;
The day before colonoscopy; To take the one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 4 PM.
The day of colonoscopy; To take one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 9:45 AM.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria All patients provided written, informed consent. All consecutive inpatients of both sexes aged 20 years and older who were scheduled for mainly therapeutic colonoscopy such as polypectomy, endoscopic mucosal resection, and endoscopic submucosal dissection at ACCH.
Key exclusion criteria Patients with the following clinical features were excluded: significant cardiac, renal, hepatic, or metabolic co-morbidities, ascites, severe constipation (<2 bowel movements per week), known allergy to PEG-ELS, history of gastric stapling or bypass procedure, or history of prior colonic or rectal surgery. Patients were excluded if there was a suspected diagnosis of intestinal obstruction because of advanced colorectal cancer.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Tajika
Organization Aichi Cancer Center Hospital
Division name Endoscopy
Zip code 464-8681
Address 1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL 052-762-6111
Email mtajika@aichi-cc.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Tajika
Organization Aichi Cancer Center Hospital
Division name Endoscopy
Zip code 464-8681
Address 1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL 052-762-6111
Homepage URL
Email mtajika@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization EA Pharma Co., Ltd., Tokyo, Japan
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 Aichi Cancer Center Hospital
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
Tel 052-762-6111
Email irb@aichi-cc.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
2016 Year 10 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
2016 Year 08 Month 26 Day
Date of IRB
2016 Year 11 Month 01 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 01 Day
Last modified on
2019 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.