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Completed

NCT Number: NCT01697644

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

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).

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

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

Primary outcomes

  1. Linear growth (height during childhood)

  2. Final height

  3. Bone maturation

  4. Pubertal development

Secondary outcomes

  1. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Important dates

Study start
1990
Primary completion
2005
Study completion
2005
First posted
Oct 2, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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