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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02337569
Other study ID # NPC-02-4
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2015
Est. completion date November 2015

Study information

Verified date April 2019
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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