Comparison of the clinical & treatment effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency
Phase 3
- Conditions
- Growth hormone deficiency in children.
- Registration Number
- IRCT1138901181414N11
- Lead Sponsor
- Pharmacy CO. Samen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
inclusion criteria:
1-Pre-pubertal stage
2-Height standard deviation score<-3
3-Insulin growth factor-1 inappropriate for age & sex (low)
4-Growth hormone level post stimulating test by clonidine <10 ng/ml
5-Rule out of the other causes of growth hormone deficiency
exclusion criteria:
1-Acute disorders such as seizure, infection diseases
2-Turner syndrome
3-Chronic kidney disease
4-Usage prednisolone
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Growth velocity. Timepoint: 1 year. Method of measurement: assessment height, puberty status.
- Secondary Outcome Measures
Name Time Method Insulin growth factor-1,bone age. Timepoint: 6 month. Method of measurement: blood sample, radiology.