Efficacy on Height in SGA Children Treated With Growth Hormone

Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184756

Enrollment

151

Registered

2005-09-16

Start date

2002-11-30

Completion date

2006-07-31

Last updated

2017-01-13

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

Conditions

Foetal Growth Problem, Small for Gestational Age

Brief summary

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Interventions

DRUGsomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

Inclusion criteria

* Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references. * Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion criteria

* Growth Hormone Deficiency (GHD) * Treatment with any medical product which may interfere with GH effects * Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Design outcomes

Primary

Measure	Time frame
Evaluate effect on Height in SGA Children Treated with Growth Hormone	After 2 years of treatment

Secondary

Measure	Time frame
Appetite	—
Height SDS, yearly	—

Countries

Czechia, Finland, Germany, Israel, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026