Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

Pfizer

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163189

A6281271

2004-002992-17 (EudraCT Number)

Details and patient eligibility

About

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Enrollment: 98 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glucocorticosteroid treatment for 12 months at least
• Bone age < 15 years for a boy and < 13 years for a girl
• Child measured height < - 2 SD, Child currently treated by GH

Exclusion criteria

• Known diabetes (type 1 or type 2)
• A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Somatropin

Experimental group

Treatment:

Drug: Somatropin