Status:
COMPLETED
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Lead Sponsor:
Pfizer
Conditions:
Short Stature Born Small for Gestational Age (SGA)
Eligibility:
All Genders
4-8 years
Phase:
PHASE4
Brief Summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Eligibility Criteria
Inclusion
- Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01859949
Start Date
October 1 2002
End Date
August 1 2015
Last Update
May 3 2016
Active Locations (19)
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1
University of Occupational and Environmental Health Hospital
Kitakyushu, Fukuoka, Japan, 807-8555
2
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
3
Hiroshima City Hospital
Hiroshima, Hiroshima, Japan, 730-8518
4
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 078-8510