Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Short Stature Born Small for Gestational Age (SGA)

Treatments: Drug: Genotropin (somatropin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859949

A6281225 (Other Identifier)

GENASG-0021-007

2015-004552-21 (EudraCT Number)

Details and patient eligibility

About

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Enrollment: 62 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

Exclusion criteria

• Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
• Children who have received radiotherapy or chemotherapy.
• Children who have serious cardiac disease, renal disease, or hepatic disease.
• Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
• Children who have serious chronic disease.
• Children who have malignant tumor.
• Children who are allergic to m-cresol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Genotropin (somatropin)

Experimental group

Treatment:

Drug: Genotropin (somatropin)