A phase III study of JR-401 in patients with SHOX dificiency
Phase 3
Completed
- Conditions
- Short stature patients with SHOX deficiency
- Registration Number
- JPRN-jRCT2080223889
- Lead Sponsor
- JCR Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
1.The children have a diagnosis of SHOX deficiency by geneanalysis.
2.A girl patients who is clearly not a Turner syndrome base on chromosome testing.
Exclusion Criteria
Pediatric patients who have received continuous GH treatment.
Pediatric patients who have received any treatment that may have effect on the growth stimulation.
Pediatric patients with a disease that causes a short stature unrelated to SHOX deficiency.
Pediatric patients with diagnosis of Langer type middle limb bone dysplasia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Change in Height Standard Deviation Score (SDS) for chronogical Age
- Secondary Outcome Measures
Name Time Method efficacy<br>Height Standard Deviation Score (SDS) for chronogical Age