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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237288
First Posted: November 9, 2010
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zeria Pharmaceutical
November 7, 2010
November 9, 2010
October 1, 2013
September 2010
April 2013   (Final data collection date for primary outcome measure)
  • Serum ALP level [ Time Frame: 6 month ]
  • Serum phosphate level [ Time Frame: 6 month ]
Same as current
Complete list of historical versions of study NCT01237288 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Primary Hypophosphatemic Rickets
Drug: Z-521
Experimental: Z-521
Intervention: Drug: Z-521
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(®) 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • A hyperparathyroidism
Sexes Eligible for Study: All
1 Year to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01237288
10010301
No
Not Provided
Not Provided
Zeria Pharmaceutical
Zeria Pharmaceutical
Not Provided
Study Chair: Keiichi Ozono, M.D., Ph.D. Osaka University Hospital
Zeria Pharmaceutical
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP