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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02337569 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency
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Scientific title:
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A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02337569 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
The serum zinc concentrations are under the normal level before registration
Exclusion Criteria:
1. Heavy hepatitis
2. Malignant tumor
3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease,
etc.
4. The serum albumin under 2.8 g/dL
5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing
(including supplement)
6. Patient who was taking a medicine including the zinc (including supplement) within 12
weeks before registration
7. Pregnant, suspected pregnant, lactating, patients who wish to have a child
8. Patient who participated in other clinical trials within 12 weeks before registration
9. Unsuitable as a target of this clinical trial judged by doctor
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Zinc Deficiency
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Intervention(s)
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Drug: NPC-02
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Drug: Placebos
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Primary Outcome(s)
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The change amount of serum zinc concentration between starting and 8 weeks after dosing
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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