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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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.