Growth Retardation In Children With Special Pathological Conditions Or Disease

Pfizer

Status and phase: Completed; Phase 3

Conditions: Endocrine System Diseases

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163215

A6281269

Details and patient eligibility

About

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Enrollment: 46 patients

Sex: All

Ages: 11 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bone age < 13 years for a boy and < 11 years for a girl
• Naive child: Measured Height < -2.5 SD for CA
• Child currently treated by GH

Exclusion criteria

• Idiopathic short stature
• Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Somatropin

Experimental group

Treatment:

Drug: Somatropin