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
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.