CompletedPhase 4

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Netherlands75 participantsStarted 1990-10

Plain-language 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).

Who can participate

Age range3 Years – 11 Years

SexALL

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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

What they're measuring

Linear growth (height during childhood)

Final height

Bone maturation

Pubertal development

Trial details

NCT IDNCT01697644

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-05

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