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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337569
• Other study ID #: NPC-02-4
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2019
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Drug:
• NPC-02

• Placebos

Locations

Country	Name	City	State
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change amount of serum zinc concentration between starting and 8 weeks after dosing		8 weeks