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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023052
Receipt No. 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

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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
Email 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
Email sako-m@ncchd.go.jp

Sponsor
Institute Division of Gastroenterology
Department of Medical Subspecialties
National Center for Child Health and Development
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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