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

Phase 3

Completed

• Conditions: Zinc Deficiency
• Interventions: Drug: NPC-02; Drug: Placebos

• Registration Number: NCT02337569
• Lead Sponsor: Nobelpharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPC-02	NPC-02	Oral dose
Placebo	Placebos	Oral dose

Primary Outcome Measures

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

Trial Locations

Locations (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases; 🇯🇵 Osaka, Japan