CompletedPhase 3

Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

France208 participantsStarted 1993-07

Plain-language summary

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Who can participate

Age range3 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Chronological age (CA) between 3 and 10 for girls * Chronological age between 3 and 12 for boys * Height for CA below - 2 SD * Birth length for CA below -2SD Exclusion Criteria: * Endocrine disease except well-substituted hypothyroidism * Sever chronic disease * Skeletal dysplasia * Known chromosomal aberration * Ongoing treatment with steroids * Known intrauterine infection

What they're measuring

Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm

Timeframe: Baseline, 2 years

Trial details

NCT IDNCT01073605

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-05

Results submitted2010-05-06

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