Phase 3 study of KCI002 in pediatric patients

Phase 3

Completed

• Conditions: Constipation

• Registration Number: JPRN-jRCT2080224936
• Lead Sponsor: Kyowa Chemical Industry Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>bioequivalence<br>confirmatory<br>Frequency of Spontaneous Bowel Movement

Secondary Outcome Measures

Name	Time	Method
efficacy<br>bioequivalence<br>1. Percentage of subjects who did not correspond to Rome IV criteria in the last week (1 week)<br>2. Percentage of patients who had bowel movement within 24 and 48 hours after the first dose and time to first spontaneous bowel movement<br>etc.<br>safety<br>1. Adverse events and adverse drug reactions<br>2. Serum Mg concentration<br>etc.