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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033105
Receipt No. R000037649
Scientific Title Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree
Date of disclosure of the study information 2018/06/26
Last modified on 2019/06/26

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Basic information
Public title Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree
Acronym Comparison between picoprep (R) alone oral administration group and oral administration strengthening group
Scientific Title Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree
Scientific Title:Acronym Comparison between picoprep (R) alone oral administration group and oral administration strengthening group
Region
Japan

Condition
Condition Compare single oral administration group of picoprep (R) and oral administration strengthening group
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study on degree of intestinal cleansing in picoprep (R) alone oral administration group and internal medicine strengthening group
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal washing degree(using Ottawa scale)
Key secondary outcomes Pretreatment time, presence or absence of addition of pretreatment, endoscope insertion time, endoscopic observation time, endoscope insertion rate, presence or absence of complications accompanying intestinal wash fluid administration, Adenoma detection rate (ADR), polyp detection rate (PDR ), mean number of adenomas per patients (MAP), patient acceptance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Picosulfate sodium 0.75% 5 ml oral administration
Interventions/Control_2 Picosulfate sodium 0.75% 5 ml non-oral dosage
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 (1) Patients who need colonoscopy
(2) Patients whose age ranges from 20 to 80
(3) Patients who explained and understood the outline of this research and obtained written informed consent
Key exclusion criteria (1) Patients who have undergone colon surgery (excluding appendectomy, hemorrhoid surgery, past endoscopic procedures)
(2) Patients with colon lesions for preoperative examination purposes or for endoscopic treatment purposes
(3) Patients with inflammatory bowel disease
(4) Patients with uncontrolled angina, myocardial infarction within the past 3 months, congestive heart failure or uncontrolled hypertension
(5) Patients who allergy of PIcoprep and Picosulfate sodium.
(6) Patients who are not suitable to this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hisabe
Middle name
Last name Takashi
Organization Fukuoka University Chikushi Hospital
Division name Gastroenterology
Zip code 8180067
Address 1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
TEL 092-921-1011
Email hisabe@cis.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name Terasawa
Middle name
Last name Masaaki
Organization Fukuoka University Chikushi Hospital
Division name Gastroenterology
Zip code 818-0067
Address 1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
TEL 092-921-1011
Homepage URL
Email masaakiterasawa@gmail.com

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukuoka University Chikushi Hospital
Address 1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
Tel 092-921-1011
Email chikushi@adm.fukuoka-u.ac.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
2018 Year 06 Month 26 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
2018 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 26 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
2018 Year 06 Month 22 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037649

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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