Clinical trial NCT01859949: Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Official title: Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Short Stature Born Small for Gestational Age (SGA)
Keywords: Genotropin(somatropin)
SGA
Short Stature
Long-term
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Month 12 (at the end of previous study) to 156
Secondary outcomes:
measure: Height Velocity Standard Deviation Score (SDS) for Chronological Age
timeFrame: Month 12 (at the end of previous study) to 156
measure: Height Velocity
timeFrame: Month 12 (at the end of previous study) to 156
measure: Height SDS for Chronological Age
timeFrame: Month 12 (at the end of previous study) to 156
measure: Height Velocity SDS for Bone Age
timeFrame: Month 12 (at the end of previous study) to 156
measure: Height SDS for Bone Age
timeFrame: Month 12 (at the end of previous study) to 156
Other outcomes:
Locations:
city: Kita-Kyushu
country: Japan
facility: University of Occupational and Environmental Health Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Obihiro
country: Japan
facility: Hokkaido Social Service Association Obihiro Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Izumi
country: Japan
facility: Osaka Medical Center and Research Institute for Maternal and Child Health
state: Osaka
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Minato-ku
country: Japan
facility: Federal Officers' Mutual Aid Association Toranomon Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Chuo
country: Japan
facility: Yamanashi University Hospital
state: Yamanashi
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka Employees' Pension Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: