UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of utility and safety of new laxative (Moviprep) for preparation of colonoscopy in patients with inflammatory bowel diseases
Acronym	Evaluation of new laxative in IBD patients
Scientific Title	Evaluation of utility and safety of new laxative (Moviprep) for preparation of colonoscopy in patients with inflammatory bowel diseases
Scientific Title:Acronym	Evaluation of new laxative in IBD patients
Region	Japan

Condition
Condition	inflammatory bowel diseases
Classification by specialty	Medicine in general Gastroenterology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of utility and safety of new laxative (Moviprep) for patients with inflammatory bowel diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clensing effects of laxatives
Key secondary outcomes	Persentage of patients who underwent colonoscopy Dose and time of laxatives for the preparation of colonoscopy Changes of body weight Blood chemistry and urine examination Clinical activity after colonoscopy Capability of using laxatives Adverse enents

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	patients who take Moviprep
Interventions/Control_2	patients who take Niflec
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	IBD patients who undergo colonoscopy or transanal balloon enteroscopy IBD patients who can take laxative IBD patients who has wtitten informed consent form IBD patinets whose age are over 17 years old
Key exclusion criteria	Patients who has obstruction and/or suspicious obstruction of gastorointestinal tract Patients who has perforation and/or suspicious perforation ofgastorointestinal tract Patients who has delayed exhaust in stomach Patients with toxic megacolon Patients who has allergy of laxatives Patinets who are determiend not to be appropriate for this study
Target sample size	80

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	Department of 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	Department of 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	2013 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	80
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	2013 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date	2013 Year 06 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	2013 Year 04 Month 29 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012404