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Clinical Trials/NCT02337569
NCT02337569
Completed
Phase 3

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

Nobelpharma1 site in 1 country57 target enrollmentJanuary 2015

Overview

Phase
Phase 3
Intervention
NPC-02
Conditions
Zinc Deficiency
Sponsor
Nobelpharma
Enrollment
57
Locations
1
Primary Endpoint
The change amount of serum zinc concentration between starting and 8 weeks after dosing
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
November 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nobelpharma
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The serum zinc concentrations are under the normal level before registration

Exclusion Criteria

  • Heavy hepatitis
  • Malignant tumor
  • Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
  • The serum albumin under 2.8 g/dL
  • Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
  • Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
  • Pregnant, suspected pregnant, lactating, patients who wish to have a child
  • Patient who participated in other clinical trials within 12 weeks before registration
  • Unsuitable as a target of this clinical trial judged by doctor

Arms & Interventions

NPC-02

Oral dose

Intervention: NPC-02

Placebo

Oral dose

Intervention: Placebos

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

Study Sites (1)

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