Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

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Key information

Conditions

Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Birth length below -2 SD
Height at start below - 2 Sd

Exclusion criteria

Any endocrine or chronic disease
Any known syndrome with short stature

Treatment and study plan

Genotropin

Drug

Primary outcomes

Height, height velocity

Secondary outcomes

Side effects

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)

Important dates

Study start: 1990
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: May 3, 2007

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.

Published trials that share one or more normalized conditions with this study.

Completed