Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01697644

Enrollment

Registered

2012-10-02

Start date

1990-10-31

Completion date

2005-05-31

Last updated

2017-01-18

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. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Interventions

DRUGsomatropin

3 IU/m\^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Years to 11 Years

Healthy volunteers

Inclusion criteria

* Completion of the GHRETARD/BPD/20/NL trial * Written informed consent from child and/or parents/guardians before continuation in the extension trial

Design outcomes

Primary

Measure	Time frame
Linear growth (height during childhood)	—
Final height	—
Bone maturation	—
Pubertal development	—

Secondary

Measure	Time frame
Adverse events	—

Countries

Netherlands

Outcome results

None listed

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