?Determining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency

Phase 3

• Conditions: Short stature due to endocrine disorder.; Short stature due to endocrine disorder; E34.3

• Registration Number: IRCT20171122037571N1
• Lead Sponsor: Arya Tina Gene company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Children older than 2 and younger than 10 for girls and 11 for boys.
Short stature with height standard deviation score (HSDS)?-3SD,<brNo increase in growth hormone more than 10 or 20 mlU/L after fasting and clonidine stimulating test
Signing the written informed consent by the gradians and assent by children older than 7

Exclusion Criteria

Any history of using GH or history of using estrogen of adrenal androgens within last year.
History of seizure, sleep apnea syndrome or other respiratory disorders.
Concomitant use of corticosteroid
Any chronic systemic disorders such as hypothyroidism, DM, rickets, skeletal dysplasia, pervious chromosomal abnormalities
Sensitivity to GH
History of chemotherapy of radiotherapy
Children with psychosocial dwarfism or idiopathic or familial short stature
Children with idiopathic or familial short stature
Spinal disorders such as scoliosis, kyphosis, chiari malformation, spinabifida variations

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body height. Timepoint: Before treatment and 3, 6, 9 and 12 months later. Method of measurement: Using harpenden wall mounted stadiometer.

Secondary Outcome Measures

Name	Time	Method
Insulin-Like Growth Factor 1 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.;Insulin-like growth factor-binding protein 3 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.;Bone age wrist. Timepoint: Before treatment and 12 months later. Method of measurement: Left wrist x-ray.;Weight. Timepoint: Before treatment and 3,6,9 and 12 months later. Method of measurement: Scale.