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.
Investigators
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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