UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of pre-treatment of additional water-supplementation in order to induce the sufficient effects of Moviprep
Acronym	Additional water supplementation effects in the use of Moviprep
Scientific Title	Evaluation of pre-treatment of additional water-supplementation in order to induce the sufficient effects of Moviprep
Scientific Title:Acronym	Additional water supplementation effects in the use of Moviprep
Region	Japan

Condition
Condition	The purpose of this study is to induce the sufficient effects of Moviprep by comparison with or wothout water-supplementation
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to induce the sufficient effects of Moviprep by comparison with or without water-supplementation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cleansing effects of large bowel for the colonoscop including of total laxative volume, preparation time, endoscopic evaluation
Key secondary outcomes	Urinary osmotic pressure and specific gravity, patients' tolerability and safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -investigator(s) and 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	Other
Interventions/Control_1	water-supplementation
Interventions/Control_2	without water-supplementation
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are tolerated to colonoscopy and Moviprep preparation. Patients who has informed consents. Patients whose age are 18 and more.
Key exclusion criteria	Patients who have or who are suspected to have gastrointestinal obstruction. Patients who has intestinal perforation. Patients who has delayed outlet of stomach. Patients who has toxic megacolon. Patients who allergy of Moviprep. Patients who are not suitable to this study.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Gastroenterology and hepatology
Zip code
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Gastroenterology and hepatology
Zip code
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
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
Address
Tel
Email

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	2014 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	0
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	2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 09 Month 15 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017634