Growth Hormone Treatment in Short Children Born Small for Gestational Age

Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191529

Enrollment

200

Registered

2005-09-19

Start date

2002-12-31

Completion date

2007-06-30

Last updated

2007-06-15

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

Conditions

Infant, Small for Gestational Age

Brief summary

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Interventions

DRUGsomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion criteria

* Born small for gestational age * actual body height less than or equal -3 SDS * chronological age greater than 3 years

Exclusion criteria

* Growth hormone deficiency * any defined syndromal disease * Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
The 2 different doses used are non-inferior to each other	—

Secondary

Measure	Time frame
Safety profiles	—
Compare absolute height velocity	—

Countries

Germany

Outcome results

None listed

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