Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Novo Nordisk A/S75 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Foetal Growth Problem Small for Gestational Age

Interventions

somatropinDRUG

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

somatropinDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (2)

Novo Nordisk Investigational Site

Rotterdam, Netherlands

Novo Nordisk Investigational Site

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Linear growth (height during childhood)

Final height

Bone maturation

Pubertal development

Secondary Outcomes

Adverse events

Data from ClinicalTrials.gov

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