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OpenTrials
Completed

NCT Number: NCT00184756

Efficacy on Height in SGA Children Treated With Growth Hormone

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Brno, Czechia

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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 with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
  • Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion criteria

  • Growth Hormone Deficiency (GHD)
  • Treatment with any medical product which may interfere with GH effects
  • Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Evaluate effect on Height in SGA Children Treated with Growth Hormone

    Time frame: After 2 years of treatment

Secondary outcomes

  1. Appetite

  2. Height SDS, yearly

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jan 13, 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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