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

Phase 3

Completed

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

• Registration Number: NCT02321865
• Lead Sponsor: Nobelpharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Study Start: 2015-01-21
• Status Verified: 2015-07
• Primary Completion: 2015-11
• Study Completion: 2015-11-24
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-02	NPC-02	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

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