JRCT ID: jRCT2031220631
Registered date:09/02/2023
Phase 3 study2 of KCI002 in pediatric patients
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Constipation |
Date of first enrollment | 15/02/2023 |
Target sample size | 50 |
Countries of recruitment | |
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. |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Yuya Yoshimura |
Address | 2876-2, Inoue, Miki-cho, Kita-gun, Kagawa, Japan Kagawa Japan 761-0705 |
Telephone | +81-87-813-5545 |
yoshimura.yuya@magmitt.co.jp | |
Affiliation | Magmitt Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Yuya Yoshimura |
Address | 2876-2, Inoue, Miki-cho, Kita-gun, Kagawa, Japan Kagawa Japan 761-0705 |
Telephone | +81-87-813-5545 |
yoshimura.yuya@magmitt.co.jp | |
Affiliation | Magmitt Pharmaceutical Co., Ltd. |