Back to resultsTherapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Primary Purpose
Primary Hypophosphatemic Rickets
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Z-521
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypophosphatemic Rickets
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.
Exclusion Criteria:
- A hyperparathyroidism
Sites / Locations
- Chiba Children's Hospital
- Kanagawa Children's Medical Center
- Osaka University Hospital
- Tokyo Metropolitan Children's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Z-521
Arm Description
Outcomes
Primary Outcome Measures
Serum ALP level
Serum phosphate level
Secondary Outcome Measures
Full Information
NCT ID
NCT01237288
First Posted
November 7, 2010
Last Updated
September 30, 2013
Sponsor
Zeria Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01237288
Brief Title
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Official Title
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypophosphatemic Rickets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Z-521
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Z-521
Primary Outcome Measure Information:
Title
Serum ALP level
Time Frame
6 month
Title
Serum phosphate level
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.
Exclusion Criteria:
A hyperparathyroidism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keiichi Ozono, M.D., Ph.D.
Organizational Affiliation
Osaka University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chiba Children's Hospital
City
Chiba
Country
Japan
Facility Name
Kanagawa Children's Medical Center
City
Kanagawa
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24532956
Citation
Ozono K, Hasegawa Y, Minagawa M, Adachi M, Namba N, Kazukawa I, Kitaoka T, Asakura Y, Shimura A, Naito Y. Therapeutic use of oral sodium phosphate (phosribbon((R)) combination granules) in hereditary hypophosphatemic rickets. Clin Pediatr Endocrinol. 2014 Jan;23(1):9-15. doi: 10.1292/cpe.23.9. Epub 2014 Feb 3.
Results Reference
derived
Learn more about this trial
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
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