Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA) (NCT01859949) | Clinical Trial Compass
CompletedPhase 4
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Japan62 participantsStarted 2002-10
Plain-language summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Who can participate
Age range4 Years – 8 Years
SexALL
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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.
What they're measuring
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Month 12 (at the end of previous study) to 156