Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

September 30, 2013 updated by: Zeria Pharmaceutical
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

      • Chiba, Japan
        • Chiba Children's Hospital
      • Kanagawa, Japan
        • Kanagawa Children's Medical Center
      • Osaka, Japan
        • Osaka University Hospital
      • Tokyo, Japan
        • Tokyo Metropolitan Children's Medical Center

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

1 year to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.

Exclusion Criteria:

  • A hyperparathyroidism

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Z-521

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum ALP level
Time Frame: 6 month
6 month
Serum phosphate level
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Investigators

  • Study Chair: Keiichi Ozono, M.D., Ph.D., Osaka University Hospital

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.

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

September 1, 2010

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

November 7, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

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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