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Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00212368
First received: September 13, 2005
Last updated: September 9, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.


Condition Intervention Phase
Wison's Disease
 Drug: Zinc acetate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.

Resource links provided by NLM:

MedlinePlus related topics: Wilson Disease
U.S. FDA Resources

Further study details as provided by Nobelpharma:

Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Wilson's disease(adult,infant,pregnant woman)

Exclusion Criteria:

  • acute hepatitis
  • malignant tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212368

Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Koudou Ishii, M.D. National MINAMIYOKOHAMA Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212368     History of Changes
Other Study ID Numbers: NPC-02-1
Study First Received: September 13, 2005
Last Updated: September 9, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
 Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Metabolic Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013