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NCT01237288 Clinical Trial

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

Primary Hypophosphatemic Rickets Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01237288
Other study ID # 10010301
Secondary ID
Status Completed
Phase Phase 3
First received November 7, 2010
Last updated September 30, 2013
Start date September 2010
Est. completion date July 2013

Study information
Verified date September 2013
Source Zeria Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 14 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- A hyperparathyroidism

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Z-521

Locations
Country Name City State
Japan Chiba Children's Hospital Chiba
Japan Kanagawa Children's Medical Center Kanagawa
Japan Osaka University Hospital Osaka
Japan Tokyo Metropolitan Children's Medical Center Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum ALP level 6 month Yes
Primary Serum phosphate level 6 month Yes