Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697644

GHRETARD/NL/21

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Low dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

High dose

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin