UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000026466