Short Stature Born Small for Gestational Age (SGA) Clinical Trial
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)
| Verified date | February 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 8 Years |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Asahikawa Medical University Hospital | Asahikawa | Hokkaido |
| Japan | Yamanashi University Hospital | Chuo | Yamanashi |
| Japan | Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka |
| Japan | Hiroshima City Hospital | Hiroshima | |
| Japan | Osaka Medical Center and Research Institute for Maternal and Child Health | Izumi | Osaka |
| Japan | University of Occupational and Environmental Health Hospital | Kita-Kyushu | Fukuoka |
| Japan | Kumamoto University Hospital | Kumamoto | |
| Japan | Kyoto University Hospital | Kyoto | |
| Japan | Gunma University Hospital | Maebashi | Gunma |
| Japan | Federal Officers' Mutual Aid Association Toranomon Hospital | Minato-ku | Tokyo |
| Japan | Iwate Medical University Hospital | Morioka | Iwate |
| Japan | Hokkaido Social Service Association Obihiro Hospital | Obihiro | Hokkaido |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Osaka Employees' Pension Hospital | Osaka | |
| Japan | Kitasato University Hospital | Sagamihara | Kanagawa |
| Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
| Japan | Tohoku University Hospital | Sendai | Miyagi |
| Japan | National Center for Child Health and Development | Setagaya-ku | Tokyo |
| Japan | Tottori University Hospital | Yonago | Tottori |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Month 12 (at the end of previous study) to 156 | Yes | |
| Secondary | Height Velocity Standard Deviation Score (SDS) for Chronological Age | 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. |
Month 12 (at the end of previous study) to 156 | No |
| Secondary | Height Velocity | Height velocity is the yearly height gain | Month 12 (at the end of previous study) to 156 | No |
| Secondary | Height SDS for Chronological Age | 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. |
Month 12 (at the end of previous study) to 156 | No |
| Secondary | Height Velocity SDS for Bone Age | 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. |
Month 12 (at the end of previous study) to 156 | No |
| Secondary | Height SDS for Bone Age | 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. |
Month 12 (at the end of previous study) to 156 | No |