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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038315
Receipt No. R000043050
Scientific Title The effect of additional macrogol 4000 in colonoscopy pretreatment for patients with chronic constipation
Date of disclosure of the study information 2019/10/16
Last modified on 2020/04/27

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Basic information
Public title The effect of additional macrogol 4000 in colonoscopy pretreatment for patients with chronic constipation
Acronym The effect of additional macrogol 4000 in colonoscopy pretreatment for patients with chronic constipation
Scientific Title The effect of additional macrogol 4000 in colonoscopy pretreatment for patients with chronic constipation
Scientific Title:Acronym The effect of additional macrogol 4000 in colonoscopy pretreatment for patients with chronic constipation
Region
Japan

Condition
Condition Patients with chronic constipation scheduled for colonoscopy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of bowel preparation for colonoscopy using Magcorol 4000 plus polyethylene glycol
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of adequate bowel preparation; defined as Boston Bowel Preparation Scale is higher than 6
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Addition macrogol4000 to polyethylene glycol for bowel preparation of colonoscopy
Interventions/Control_2
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 1) Patients with chronic constipation scheduled to undergo colonoscopy screening
2) Over 20 years old
3) After the informed consentfor participation in this study, the consent document by the voluntary will is obtained.
Key exclusion criteria 1) Those who have colorectal lesions and are intended for preoperative examination or endoscopic treatment
2) Those who have undergone intestinal surgery resection (excluding appendectomy and hemorrhoid surgery)
3) Those who has not functional chronic constipation
4) Those who have familial colorectal adenomatosis
5) inflammatory bowel disease
6) Those who have advanced renal dysfunction
7) Those who have difficulty taking internal preparations for colonoscopy
8) Pregnant women, breastfeeding
9) Those who are allergic to study drug
10) Those who regularly use Macrogol 4000
11) Those who have not given consent to participate in this clinical study
12) Others who are deemed inappropriate as subjects
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Sho
Middle name
Last name Suzuki
Organization Nihon University School of Medicine, Tokyo, Japan
Division name Division of Gastroenterology and Hepatology, Department of Medicine
Zip code 101-8309
Address 1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo, Japan
TEL 0332931711
Email s.sho.salubriter.mail@gmail.com

Public contact
Name of contact person
1st name Ryoji
Middle name
Last name Ichijima
Organization Nihon University School of Medicine, Tokyo, Japan
Division name Division of Gastroenterology and Hepatology, Department of Medicine
Zip code 101-8309
Address 1-6 Kanda-Surugadai, Chiyoda-ku,Tokyo, Japan
TEL 0332931711
Homepage URL
Email ryoji0331@yahoo.co.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon University Hospital
Address 1-6 Kanda-Surugadai, Chiyoda-ku
Tel 03-3291-1711
Email ryoji0331@yahoo.co.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 日本大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 16 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 20 Day
Date of IRB
2019 Year 10 Month 10 Day
Anticipated trial start date
2019 Year 10 Month 21 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 16 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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