Phase 3 study2 of KCI002 in pediatric patients

Phase 3 study2 of KCI002 in pediatric patients with constipation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220631

Enrollment

Registered

2023-02-09

Start date

2023-02-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Interventions

-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

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Constipation patients based on congenital organic disease 2. Patients with renal impairment. 3. Patients diagnosed with hypermagnesemia etc.

Design outcomes

Primary

Measure	Time frame
Frequency of Spontaneous Bowel Movement.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactYuya Yoshimura

Magmitt Pharmaceutical Co., Ltd.

yoshimura.yuya@magmitt.co.jp+81-87-813-5545

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026