MedDataX Logo

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

NCT ID: NCT01237288

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Hypophosphatemic Rickets

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Z-521

Group Type EXPERIMENTAL

Z-521

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Z-521

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* A hyperparathyroidism
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zeria Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Keiichi Ozono, M.D., Ph.D.

Role: STUDY_CHAIR

Osaka University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chiba Children's Hospital

Chiba, , Japan

Site Status

Kanagawa Children's Medical Center

Kanagawa, , Japan

Site Status

Osaka University Hospital

Osaka, , Japan

Site Status

Tokyo Metropolitan Children's Medical Center

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24532956 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10010301

Identifier Type: -

Identifier Source: org_study_id