Phase three clinical trial of NPC-02 in children with hypozincemia
- Conditions
- Hypozincemia
- Registration Number
- JPRN-UMIN000023052
- Lead Sponsor
- Division of Gastroenterology Department of Medical Subspecialties National Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
1. Patient who is judged by investigator to have malabsorption (short gut syndrome, post-intestinal resection, deletion of ZIP4 gene, etc.) 2. Patient whose serum albumin is no more than 80% of institutional range 3. Patient who receives parenteral nutrition at the time or within 8 weeks of registration 4. Patient who may require parenteral nutrition or fasting during clinical trial (registration-last visit or termination of trial) 5. Patient who has taken prohibited zinc containing medicine or supplement within 12 weeks before registration 6. Patient applying zinc containing dermatological preparations 7. Patient whose renal function is impaired (estimated glomerular infiltration rate < 60 mL/min/1.73m2) 8. Patient whose hepatobiliary enzymes (AST, ALT, GGTP) or amylase is more than twice the institutional normal range 9. Patient with known allergy or hypersensitivity to zinc containing medical products (including supplement) 10. Patient with malignant tumor 11. Patient with severe heart disease, hematological disorder, etc. 12. Woman after menarche who are pregnant, suspicious of pregnant, wishing to get pregnant, or lactating 13. Patient who participated in other clinical trials within 12 weeks before registration 14. Patient who are judged unsuitable for this clinical trial by the conducting physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients whose serum zinc concentration reached above 80 microgram/dL after 8 weeks administration of NPC-02 with the same dose
- Secondary Outcome Measures
Name Time Method 1. Change of serum zinc concentration 2. Proportion of zinc dose to reach the serum zinc concentration above 80 microgram/dL 3. Proportion of zinc dose required to raise the serum zinc concentration above 15 microgram/dL from the original concentration 4. Symptoms associated with hypozincemia