UMIN-CTR Clinical Trial

Basic information
Public title	Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy
Acronym	Safety of bowel cleasing agents
Scientific Title	Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy
Scientific Title:Acronym	Safety of bowel cleasing agents
Region	Japan

Condition
Condition	Colorectal diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A new low-volume, sodium phosphate-free polyethylene glycol (2-L Moviprep) has been available at conventional colonoscopy since June 2013 in Japan. Safety of Movipreps has not been well discussed at conventional colonoscopy and colon capsule endoscopy for aged patients, and patients with chronic renal or heart failure. In this study, we determine the safety of bowel cleansing agents at conventional colonoscopy and colon capsule endoscopy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Vital sign, blood and urine analysis before and after colonic examination
Key secondary outcomes	Cleasing grades, duration of bowel cleasing, and acceptablity of cleasing agents.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Male and female older than 19 years old which were diagnosed or suspected to have colorectal diseases.
Key exclusion criteria	1)Patients with dysphasia 2)Patietns who had allergy to agents used in this study. 3)Pregnant or possible pregnant women 4)Patients who will undergo MRI 2 weeks after colon capsule endoscopy 5)Patients with small and large bowel obstruction 6)Patients with stricture in small and large bowel 7)Patients with glucose-6-phosphate dehydrogenase deficiency
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi Prefecture, Japan
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi Prefecture, Japan
TEL	0562-93-9240
Homepage URL
Email	nohmiya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization	Ajinomoto Pharmaceuticals CO., LDT
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
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	藤田保健衛生大学（愛知県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 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	2013 Year 11 Month 05 Day
Date of IRB	2015 Year 03 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 20 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 01 Month 06 Day
Date analysis concluded	2021 Year 01 Month 31 Day

Other
Other related information	57 patients with CKD were enrolled.

Management information
Registered date	2014 Year 02 Month 01 Day
Last modified on	2021 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015218