Back to resultsLong Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Primary Purpose
Short Stature Born Small for Gestational Age (SGA)
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Genotropin (somatropin)
Sponsored by
About this trial
This is an interventional treatment trial for Short Stature Born Small for Gestational Age (SGA) focused on measuring Genotropin(somatropin), SGA, Short Stature, Long-term, Safety
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.
Sites / Locations
- University of Occupational and Environmental Health Hospital
- Gunma University Hospital
- Asahikawa Medical University Hospital
- Hokkaido Social Service Association Obihiro Hospital
- Hokkaido University Hospital
- Iwate Medical University Hospital
- Kitasato University Hospital
- Tohoku University Hospital
- Osaka Medical Center and Research Institute for Maternal and Child Health
- Seirei Hamamatsu General Hospital
- Federal Officers' Mutual Aid Association Toranomon Hospital
- National Center for Child Health and Development
- Tottori University Hospital
- Yamanashi University Hospital
- Hiroshima City Hospital
- Kumamoto University Hospital
- Kyoto University Hospital
- Okayama University Hospital
- Osaka Employees' Pension Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genotropin (somatropin)
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary Outcome Measures
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.
Height Velocity
Height velocity is the yearly height gain
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01859949
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature Born Small for Gestational Age (SGA)
Keywords
Genotropin(somatropin), SGA, Short Stature, Long-term, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genotropin (somatropin)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Genotropin (somatropin)
Intervention Description
Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Month 12 (at the end of previous study) to 156
Secondary Outcome Measure Information:
Title
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Description
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.
Time Frame
Month 12 (at the end of previous study) to 156
Title
Height Velocity
Description
Height velocity is the yearly height gain
Time Frame
Month 12 (at the end of previous study) to 156
Title
Height SDS for Chronological Age
Description
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.
Time Frame
Month 12 (at the end of previous study) to 156
Title
Height Velocity SDS for Bone Age
Description
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.
Time Frame
Month 12 (at the end of previous study) to 156
Title
Height SDS for Bone Age
Description
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.
Time Frame
Month 12 (at the end of previous study) to 156
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Occupational and Environmental Health Hospital
City
Kita-Kyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Asahikawa Medical University Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Hokkaido Social Service Association Obihiro Hospital
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0805
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka Medical Center and Research Institute for Maternal and Child Health
City
Izumi
State/Province
Osaka
ZIP/Postal Code
594-1101
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Federal Officers' Mutual Aid Association Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
National Center for Child Health and Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Yamanashi University Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Hiroshima City Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Employees' Pension Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=GENASG-0021-007&StudyName=Long%20Term%20Study%20of%20Genotropin%20%28Somatropin%29%20for%20Short%20Children%20Born%20Small%20for%20Gestational%20Age%20%28SGA%29
Description
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Learn more about this trial
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
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