Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
- Conditions
- Short Stature Born Small for Gestational Age (SGA)
- Interventions
- Registration Number
- NCT01859949
- Lead Sponsor
- Pfizer
- Brief Summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Genotropin (somatropin) Genotropin (somatropin) -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Month 12 (at the end of previous study) to 156
- Secondary Outcome Measures
Name Time Method Height SDS for Chronological Age Month 12 (at the end of previous study) to 156 Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values on the participant age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.Height Velocity SDS for Bone Age Month 12 (at the end of previous study) to 156 To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.Height Velocity Standard Deviation Score (SDS) for Chronological Age Month 12 (at the end of previous study) to 156 Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values of the participants age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.Height Velocity Month 12 (at the end of previous study) to 156 Height velocity is the yearly height gain
Height SDS for Bone Age Month 12 (at the end of previous study) to 156 To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Trial Locations
- Locations (19)
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
University of Occupational and Environmental Health Hospital
🇯🇵Kita-Kyushu, Fukuoka, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Hokkaido Social Service Association Obihiro Hospital
🇯🇵Obihiro, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
🇯🇵Izumi, Osaka, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Federal Officers' Mutual Aid Association Toranomon Hospital
🇯🇵Minato-ku, Tokyo, Japan
Tottori University Hospital
🇯🇵Yonago, Tottori, Japan
Yamanashi University Hospital
🇯🇵Chuo, Yamanashi, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Osaka Employees' Pension Hospital
🇯🇵Osaka, Japan
National Center for Child Health and Development
🇯🇵Setagaya-ku, Tokyo, Japan