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Completed

NCT Number: NCT02321865

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

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.

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Key information

Conditions

Zinc Deficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, 537-8511, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The serum zinc concentrations are under the nomal level before registration
  • Able to taking a tablet

Exclusion criteria

  • Heavy hepatitis
  • Malignant tumor
  • Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
  • The serum albumin under 2.8 g/dL
  • Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
  • Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
  • Pregnant, suspected pregnant, lactating, patients who wish to have a child
  • Patient who participated in other clinical trials within 12 weeks before registration
  • Unsuitable as a target of this clinical trial judged by doctor

Treatment and study plan

NPC-02

Drug

Primary outcomes

  1. The ratio of the patients who could maintain target serum zinc concentration

    Time frame: approx. 12-24 weeks

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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