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

A prospective Phase III, Multicentre, Randomised, Open Label 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/003957

Enrollment

Registered

2013-09-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Growth hormone deficiency in pre-pubertal children(4 to 12 years).

Interventions

Intervention1: USV&#039

s Somatropin: Total weekly dose of 0.24mg/kg body weight administered in equal doses,subcutaneously,for 6 months. Control Intervention1: LG Eutropin(Somatropin): Total weekly dose of 0.24mg/kg body we

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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 treatment 3. Known hypersenitivity to the Investigational products 4.Any systemic disorder likely to affect pharmacological action of somatropin.

Design outcomes

Primary

Measure	Time frame
1) Height 2) Height Standard Deviation Score 3) Height Velocity 4) Height Velocity Standard Deviation ScoreTimepoint: 6 months	—

Secondary

Measure	Time frame
1) Insulin-like Growth Factor-1 2) Insulin-like Growth Factor-Binding Protein-3Timepoint: Measured at 0,3 and 6 months.	—

Countries

India

Contacts

Public ContactKapil Arora

Apothecaries Private Limited

kapil.arora@apothecaries.net01124502551

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026