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Comparison of the clinical & treatment effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency

Comparison of the short & long term effects and side effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency: double-blind randomized clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT1138901181414N11
Enrollment
22
Registered
2010-09-14
Start date
2006-08-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Growth hormone deficiency in children.

Interventions

Intervention 1: treatment intervention by 0.04 mg/kg/day Samen recombinant growth hormone in subcutaneous way for one year in intervention group. Intervention 2: treatment intervention by daily subcu
Treatment - Drugs
treatment intervention by 0.04 mg/kg/day Samen recombinant growth hormone in subcutaneous way for one year in intervention group
treatment intervention by daily subcutaneous injection 30 microgram/kilogram weight of NOVO recombinant growth hormone for one year in control group

Sponsors

Pharmacy CO. Samen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 13 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Growth velocity. Timepoint: 1 year. Method of measurement: assessment height, puberty status.

Secondary

MeasureTime frame
Insulin growth factor-1,bone age. Timepoint: 6 month. Method of measurement: blood sample, radiology.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 18, 2026