UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023052 |
|---|---|
| Receipt number | R000026466 |
| Scientific Title | Phase three clinical trial of NPC-02 in children with hypozincemia |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2019/09/12 10:03:52 |
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Basic information
Public title
Phase three clinical trial of NPC-02 in children with hypozincemia
Acronym
Phase three clinical trial of NPC-02 in children with hypozincemia
Scientific Title
Phase three clinical trial of NPC-02 in children with hypozincemia
Scientific Title:Acronym
Phase three clinical trial of NPC-02 in children with hypozincemia
Region
| Japan |
Condition
Condition
Hypozincemia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of NPC-02 granules in children with hypozincemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Proportion of patients whose serum zinc concentration reached above 80 microgram/dL after 8 weeks administration of NPC-02 with the same dose
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The dose of NPC-02 granules will be determined by the weight and the age of patients, and it will be administered twice a day at 30-60 minutes after morning and evennge meals
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient whose fasting serum zinc concentration are above 30 microgram/dL and under 70 microgram/dL both at the time and within 8 weeks before registration
2. Data from original medical record which was documented within 8 weeks and over 1week before registration can be used for patient screening
3. Serum zinc concentration at the time and within 8 weeks before registration needs to be at least 1 week apart
4. Fasting is defined as equal or more than 4 hours after meal or tube feeding
5. Patient whose age at the time of registration is above 1 month and under 18 year-olds. No limitation with sex, or setting (outpatient/hospitalized). Premature infant whose corrected age is less than 1 month is excluded.)
6. Written consent to participate in this clinical trial must be obtained from legal guardian
Key exclusion criteria
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
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Arai |
Organization
National Center for Child Health and Development
Division name
Division of Gastroenterology, Department of Medical Subspecialties
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo, 157-8535, Japan
TEL
03-3416-0181
arai-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sako |
Organization
National Center for Child Health and Development
Division name
Division for Clinical Trials, Department of Clinical Research
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo, 157-8535, Japan
TEL
03-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
Division of Gastroenterology
Department of Medical Subspecialties
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in National Center for Child Heath and Development
Address
2-10-1 Okura, Setagaya, Tokyo, 157-8535, Japan
Tel
03-3416-0181
seiiku-chiken@ncchd.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
16lk0201047h0001
Org. issuing International ID_1
Japan Agency for Medical Research and Development
Study ID_2
Org. issuing International ID_2
IND to MHLW
28-1042
Institutions
Institutions
国立研究開発法人国立成育医療研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026466
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
