臨床研究等提出・公開システム

Date of registration	Nov. 06, 2019
Last modified on	Mar. 02, 2022
Trial ID	jRCT2080224936

Scientific Title	Phase 3 study of KCI002 in pediatric patients with constipation
Public Title	Phase 3 study of KCI002 in pediatric patients

Completion Date or Terminated date	Mar. 31, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Kyowa Chemical Industry Co., Ltd.
	Address	-
	Phone Number	-
	E-mail Address	yuyayoshimura@kyowa-chem.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Kyowa Chemical Industry Co., Ltd.
	Address	-
	Phone Number	-
	E-mail Address	yuyayoshimura@kyowa-chem.co.jp

Recruitment Status	completed

Date of First Enrolment		Dec. 16, 2019
Target Sample Size		60
Study Type		Interventional
Study Design	Study Design	Multicenter, placebo controlled, and double blind study, open-label continuous administration study, equivalence study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who correspond to Rome IV criteria 2. Patients whose serum Mg level is within the standard range etc.
	Exclusion Criteria	1. Constipation patients based on congenital organic disease 2. Patients with renal impairment 3. Patients diagnosed with hypermagnesemia etc.
	Minimum Age	1age old over
	Maximum Age	14age old under
	Gender	Both
Health Condition or Problem Studied		Constipation
Intervention(s)		investigational material(s) Generic name etc : KCI002 INN of investigational material : Magnesium Oxide Therapeutic category code : 235 Purgatives and clysters Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy bioequivalence confirmatory Frequency of Spontaneous Bowel Movement
Secondary Outcome		efficacy bioequivalence 1. Percentage of subjects who did not correspond to Rome IV criteria in the last week (1 week) 2. Percentage of patients who had bowel movement within 24 and 48 hours after the first dose and time to first spontaneous bowel movement etc. safety 1. Adverse events and adverse drug reactions 2. Serum Mg concentration etc.

Primary Sponsor	Kyowa Chemical Industry Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Pediatric Clinical Trials Network Central Institutional Review Board
Address of IRB	2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Saitama City Hospital Institutional Review Board
Address of IRB	2460 Mimuro, Midori-ku, Saitama, Saitama, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Yokohama Minoru Clinic Institutional Review Board
Address of IRB	1-13-8 Bessho, Minami-ku, Yokohama, Kanagawa, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Morioka Medical Center Institutional Review Board
Address of IRB	1-25-1 Aoyama, Morioka, Iwate, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Gunma University Hospital Clinical Research Review Board
Address of IRB	3-39-15, Showamachi, Maebashi, Gunma, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Juntendo University Hospital Institutional Review Board
Address of IRB	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Shinshu University Hospital Institutional Review Board
Address of IRB	3-1-1, Asahi, Matsumoto, Nagano, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Mizuo Clinic Institutional Review Board
Address of IRB	Wisteria-kan 1F, 3-9-1, Nakataminami, Izumi-ku, Yokohama, Kanagawa, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Name of IRB	Jimbo Orthopedics Institutional Review Board
Address of IRB	5-38-41, Honcho, Koganei, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 09, 2019

Secondary ID No.	JapicCTI-195024
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
11	Mar. 02, 2022	(this page)	Changes
10	June. 02, 2021	Detail	Changes
9	Jan. 05, 2021	Detail	Changes
8	Oct. 01, 2020	Detail	Changes
7	Aug. 31, 2020	Detail	Changes
6	July. 02, 2020	Detail	Changes
5	May. 20, 2020	Detail	Changes
4	April. 15, 2020	Detail	Changes
3	Feb. 05, 2020	Detail	Changes
2	Jan. 15, 2020	Detail	Changes
1	Nov. 11, 2019	Detail

List of change history