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OpenTrials
Completed

NCT Number: NCT01734447

Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Paris, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients born with IUGR enrolled in trial GHRETARD/F/1/F
  • Bone age below 14 years in boys and 12 years in girls

Exclusion criteria

  • Bone age above 14 years in boys and 12 years in girls

Treatment and study plan

Somatropin

Drug

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

Primary outcomes

  1. Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

Secondary outcomes

  1. Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray

  2. Pubertal development, assessed according to Tanner method

  3. Height velocity

  4. Final height

  5. Number of Adverse Events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Nov 27, 2012
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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