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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00174408
Enrollment
110
Registered
2005-09-15
Start date
1990-03-31
Completion date
2005-02-28
Last updated
2007-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Disorders

Brief summary

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)

Interventions

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Height, height velocity

Secondary

MeasureTime frame
Side effects

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026