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

Phase 3

Completed

• Conditions: Growth hormone deficiency in pre-pubertal children(4 to 12 years).

• Registration Number: CTRI/2013/09/003957
• Lead Sponsor: USV Ltd

Brief Summary

This study is a Prospective Phase III,Multicentre,randomized,Open label study to evaluate the comparative safety and efficacy of Recombinant Human Growth Hormone of USV with Eutropin in the treatment of Pre-pubertal children(4-12 years) with growth hormone deficiency.The Primary outcome measures will be Height,Height standard deviation score,height velocity and height velocity standard deviation score after 6 months.The secondary outcome will be measuring Insulin-like Growth Factor and Insulin-like Growth Factor-Binding Protein at 0,3 and 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-31
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Pre-pubertal children in the age group of 4-12 years of age.
• 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.
• GH defiency if due to pituitary surgery not earlier than 2 years and woth a stable disease.

Exclusion Criteria

• 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 treatment3.
• Known hypersenitivity to the Investigational products4.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) Height2) Height Standard Deviation Score 3) Height Velocity 4) Height Velocity Standard Deviation Score	6 months

Secondary Outcome Measures

Name	Time	Method
1) Insulin-like Growth Factor-1 2) Insulin-like Growth Factor-Binding Protein-3	Measured at 0,3 and 6 months.

Trial Locations

Locations (7)

All India Institute of Medical Science; 🇮🇳 Delhi, DELHI, India

Department of Paediatrics,; 🇮🇳 Delhi, DELHI, India

Dr. IPS Kochar clinic; 🇮🇳 Nagar, UTTAR PRADESH, India

Instride Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

MV Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Panchsheel Hospital; 🇮🇳 Delhi, DELHI, India

Shree Sai Childrens Hospital; 🇮🇳 Pune, MAHARASHTRA, India

All India Institute of Medical Science

🇮🇳Delhi, DELHI, India

Rajesh Khadgawat

Principal investigator

9868397605

rajeshkhadgawat@hotmail.com