UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013041
Receipt number R000015218
Scientific Title Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy
Date of disclosure of the study information 2014/02/01
Last modified on 2021/01/23 11:11:23

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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 or person

Institute

Fujita Health University School of Medicine, Department of Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015218


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name