UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000046015
Receipt number	R000052521
Scientific Title	A prospective, controlled, randomized, assessor-blind, comparative study of a new oral bowel cleanser (Sodium Picosulfate/Magnesium Citrate) versus existing oral bowel cleanser (Magnesium Citrate) in pediatric colonoscopy preparation.
Date of disclosure of the study information	2021/11/15
Last modified on	2025/04/23 18:01:57

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Basic information

Public title

A prospective, controlled, randomized, assessor-blind, comparative study of a new oral bowel cleanser (Sodium Picosulfate/Magnesium Citrate) versus existing oral bowel cleanser (Magnesium Citrate) in pediatric colonoscopy preparation.

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Inflammatory bowel disease, Functional gastrointestinal disorders, Eosinophilic gastroenteritis, Colorectal polyps, others

Classification by specialty

Gastroenterology Pediatrics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Investigate the bowel cleansing effect, patient acceptance and side effects of a new oral new oral bowel cleanser by comparing with existing agents.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Assessment

Primary outcomes

Bowel cleansing effect by Boston bowel preparation scale

Key secondary outcomes

Side effects (nausea, vomiting and abdominal pain during administration, electrolytes and renal function on the day of CS)
Patient acceptability (taste, ease of taking, dosage, desire for re-administration, overall evaluation) Parental acceptability (overall evaluation)

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

PICOPREP

Interventions/Control_2

MAGCOROL Powder

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

6 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Children 6-18 years old who will undergo colonoscopy in our department

Key exclusion criteria

Patients with emergency endoscopy, intestinal occlusion, toxic megacolon, electrolyte abnormalities, previous ductal resection, metabolic disorders, renal disorders, cardiac disorders, post-transplant acute GVHD suspicion, weight under 20 kg, Patients with a history of PICO administration and others(treating physicians judged as inappropriate)

Target sample size

126

Research contact person

Name of lead principal investigator

1st name Tomoko

Middle name

Last name Hara

Organization

Saitama children's Medical Center

Division name

Division of Gastroenterology and Hepatology

Zip code

330-8777

Address

1-2 Shintoshin, Chuou-ku, Saitama

TEL

048-601-2200

Email

haraping2mail@gmail.com

Public contact

Name of contact person

1st name Tomoko

Middle name

Last name Hara

Organization

Saitama children's Medical Center

Division name

Division of Gastroenterology and Hepatology

Zip code

330-8777

Address

1-2 Shintoshin, Chuou-ku, Saitama

TEL

048-601-2200

Homepage URL

Email

haraping2mail@gmail.com

Sponsor or person

Institute

Saitama children's Medical Center
Division of Gastroenterology and Hepatology

Institute

Department

Personal name

Funding Source

Organization

Saitama children's Medical Center
Division of Gastroenterology and Hepatology

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Saitama children's Medical Center

Address

1-2 Shintoshin, Chuou-ku, Saitama

Tel

048-601-2200

Email

haraping2mail@gmail.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 11 Month 15 Day

Related information

URL releasing protocol

Publication of results

Partially published

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

2018 Year 02 Month 07 Day

Date of IRB

2018 Year 03 Month 08 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 11 Month 30 Day

Date trial data considered complete

2023 Year 03 Month 30 Day

Date analysis concluded

2025 Year 09 Month 30 Day

Other

Other related information

Management information

Registered date

2021 Year 11 Month 09 Day

Last modified on

2025 Year 04 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052521