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Completed

NCT Number: NCT00557336

Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Albacete, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
  • Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
  • Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
  • Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion criteria

  • Diabetes
  • Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
  • Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
  • History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
  • Previous or ongoing growth hormone therapy

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Height gain according to birth group, age of onset, the treatment and Tanner stage

    Time frame: during 12 months of treatment

Secondary outcomes

  1. Height SDS for bone age

    Time frame: during 12 months of treatment

  2. Height velocity SDS for bone age

    Time frame: during 12 months of treatment

  3. Height velocity for chronological age

    Time frame: during 12 months of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 14, 2007
Registry last updated
Feb 28, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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