This trial is active, not recruiting.

Condition zinc deficiency
Treatment npc-02
Phase phase 3
Sponsor Nobelpharma
Start date January 2015
End date December 2015
Trial size 40 participants
Trial identifier NCT02321865, NPC-02-5


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Nobelpharma.