A Study to Evaluate the Comparitive Safety and Efficacy of Recombinant Human Growth Hormone (rhGH) of USV with Eutropin in the Treatment of Pre-pubertal Children (4 to 12 years) with Growth Hormone Deficency
- Conditions
- Health Condition 1: null- Growth hormone deficiency in pre-pubertal children(4 to 12 years).
- Registration Number
- CTRI/2013/09/003957
- Lead Sponsor
- SV Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Pre-pubertal children in the age group of 4-12 years of age.
2. Children with short stature with a growth rate 5.0 cm per year.
3.Children with deficiency of GH testing without any organic pathology documented by dynamic GH testing by at least 2 differnent stimuli.The post stimulation level of human GH should not be / 10 ng/ml.
4. GH defiency if due to pituitary surgery not earlier than 2 years and woth a stable disease.
1.Associated endocrine disorders of thyroid function, adenocortical insufficiency(serum basal cortisol<3ug/dl) unless adequately replaced with thyroxin and showing a stable thyroid function at least for 8 weeks.
2.patients already receiving rhGH treatment
3. Known hypersenitivity to the Investigational products
4.Any systemic disorder likely to affect pharmacological action of somatropin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Height<br>2) Height Standard Deviation Score 3) Height Velocity <br>4) Height Velocity Standard Deviation ScoreTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method 1) Insulin-like Growth Factor-1 <br>2) Insulin-like Growth Factor-Binding Protein-3Timepoint: Measured at 0,3 and 6 months.