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

April 14, 2019 updated by: Nobelpharma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPC-02
Drug: NPC-02

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ratio of the patients who could maintain target serum zinc concentration
Time Frame: approx. 12-24 weeks
approx. 12-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobelpharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 24, 2015

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • NPC-02-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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