臨床研究等提出・公開システム

Date of registration	Feb. 09, 2023
Last modified on	Sept. 12, 2025
Trial ID	jRCT2031220631

Scientific Title	Phase 3 study2 of KCI002 in pediatric patients with constipation
Public Title	Phase 3 study2 of KCI002 in pediatric patients

Completion date	Jan. 27, 2024
Result actual enrolment	56
Baseline Characteristics	Pediatric patients aged 1 to less than 15 years with constipation.
Adverse events	No adverse events leading to death, serious adverse events, adverse events resulting in treatment discontinuation, or adverse events requiring the use of rescue medication were observed.
Outcome measures	In the E-FAS study, during the final week (1 week) of Phase I (double-blind period), the mean number of spontaneous bowel movements (SBMs) was 5.0 in the KCI002 treatment group and 3.2 in the placebo group. The ratio of SBMs between the KCI002 group and the placebo group was 1.55 (95% confidence interval: 1.16-2.06). A statistically significant difference in the number of SBMs between the treatment groups was observed during the final week of Phase I (p-value: 0.004). During the final week of Phase I (double-blind period), the proportion of subjects who no longer met the Rome IV diagnostic criteria was higher in the KCI002 treatment group [70.4% (19/27)] compared to the placebo group [28.6% (8/28)]
Brief summary	Regarding the efficacy of KCI002 tablets 100 mg, a statistically significant difference was observed in the primary endpoint-the number of spontaneous bowel movements (SBMs) during the final week (1 week) of Phase I (double-blind period)-between the KCI002 treatment group and the placebo group (p-value: 0.004).

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2031220631

Contact for Scientific Queries	Name	Yoshimura Yuya
	Affiliation	Magmitt Pharmaceutical Co., Ltd.
	Address	2876-2, Inoue, Miki-cho, Kita-gun, Kagawa, Japan
	Telephone	+81-87-813-5545
	E-mail	yoshimura.yuya@magmitt.co.jp
Contact for Public Queries	Name	Yoshimura Yuya
	Affiliation	Magmitt Pharmaceutical Co., Ltd.
	Address	2876-2, Inoue, Miki-cho, Kita-gun, Kagawa, Japan
	Telephone	+81-87-813-5545
	E-mail	yoshimura.yuya@magmitt.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 01, 2023
Actual date of first enrollment		Feb. 15, 2023
Target sample size		50
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
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.
	Age Minimum	1age old over
	Age Maximum	15age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Constipation
Intervention(s)		-TREATMENT1- Test arm:KCI002 is administered orally twice daily for 2 weeks. Control Arm:Placebo is administered orally twice daily for 2 weeks. -TREATMENT2- KCI002 is administered orally twice daily for 10 weeks. -TREATMENT3- Magmitt Tab.200 or Magmitt Fine Granules 83 percent is administered orally twice daily for 2 weeks.
Primary Outcome(s)		Frequency of Spontaneous Bowel Movement.
Secondary Outcome(s)		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.

Primary Sponsor	Magmitt Pharmaceutical Co., Ltd.

Name of Certified Review Board	Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8, Bessho, Minami-ku, Yokohama, Kanagawa, Japan, Kanagawa
Telephone	+81-42-648-5551
E-Mail	yminoru-irb@eps.co.jp
Approval Status	Approval
Date of approval	Dec. 15, 2022

Name of Certified Review Board	Yamauchi Clinic Institutional Review Board
Address	1-15-19, Jiyugaoka, Meguro-ku, Tokyo, Japan, Kanagawa
Telephone	+81-3-6777-1490
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval	Dec. 15, 2022

Name of Certified Review Board	Mizuo Clinic Institutional Review Board
Address	Wisteria-kan 1F, 3-9-1, Nakataminami, Izumi-ku, Yokohama, Kanagawa, Japan, Kanagawa
Telephone	+81-3-5295-0147
E-Mail	info@mizuo-irb.jp
Approval Status	Approval
Date of approval	Dec. 15, 2022

Name of Certified Review Board	National Center for Child Health and Development Institutional Review Board
Address	2-10-1, Okura, Setagaya-ku, Tokyo, Kanagawa
Telephone	+81-3-3416-0181
E-Mail	seiiku-chiken_irb@ncchd.go.jp
Approval Status	Approval
Date of approval	Dec. 15, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	Sept. 12, 2025	(this page)	Changes
8	April. 27, 2024	Detail	Changes
7	Aug. 02, 2023	Detail	Changes
6	July. 21, 2023	Detail	Changes
5	July. 08, 2023	Detail	Changes
4	April. 16, 2023	Detail	Changes
3	Feb. 28, 2023	Detail	Changes
2	Feb. 16, 2023	Detail	Changes
1	Feb. 09, 2023	Detail

List of change history