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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02337569

Enrollment

Registered

2015-01-13

Start date

2015-01-31

Completion date

2015-11-30

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Brief summary

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

Interventions

DRUGNPC-02

DRUGPlacebos

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The change amount of serum zinc concentration between starting and 8 weeks after dosing	8 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026