Phase 3 study2 of KCI002 in pediatric patients

JRCT ID: jRCT2031220631

Registered date:09/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Constipation
• Date of first enrollment: 15/02/2023
• Target sample size: 50
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Frequency of Spontaneous Bowel Movement.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 15age old
• Gender: Both

Include criteria

1. Patients who correspond to Rome IV criteria.
2. Patients whose serum Mg level is within the standard range etc.

Exclude criteria

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

Related Information

• Primary Sponsor: Yoshimura Yuya