Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

Pfizer

Status and phase: Completed; Phase 3

Conditions: Idiopathic Short Stature

Treatments: Drug: Genotropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396097

A6281280

Details and patient eligibility

About

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Enrollment: 316 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
• Naive to Growth Hormone treatment

Exclusion criteria

• Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups

Standard

Active Comparator group

Description:

Standard daily HGH treatment

Treatment:

Drug: Genotropin

Drug: Genotropin

Formula-based

Active Comparator group

Description:

Formula-based dose regimen

Treatment:

Drug: Genotropin

Drug: Genotropin