Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

Zinc Deficiency Clinical Trial

Official title:

Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321865
• Other study ID #: NPC-02-5
• Status: Completed
• Phase: Phase 3
• Start date: January 21, 2015
• Est. completion date: November 24, 2015

Study information

• Verified date: July 2015
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 24, 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Able to taking a tablet

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

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 ratio of the patients who could maintain target serum zinc concentration		approx. 12-24 weeks