Phase 3 study of KCI002 in pediatric patients

Phase 3 study of KCI002 in pediatric patients with constipation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224936

Enrollment

Registered

2019-11-06

Start date

2019-12-16

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

investigational material(s) Generic name etc : KCI002 INN of investigational material : Magnesium Oxide Therapeutic category code : 235 Purgatives and clysters Dosage and Administration for Investigat

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
efficacy bioequivalence confirmatory Frequency of Spontaneous Bowel Movement	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Outcome results

None listed

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