A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.

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Detailed Description

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Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NPC-02

Oral dose

Group Type EXPERIMENTAL

NPC-02

Intervention Type DRUG

Placebo

Oral dose

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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NPC-02

Intervention Type DRUG

Placebos

Intervention Type DRUG

Eligibility 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No