Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
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| ClinicalTrials.gov Identifier: NCT01859949 |
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Recruitment Status :
Completed
First Posted : May 22, 2013
Results First Posted : March 15, 2016
Last Update Posted : May 3, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Short Stature Born Small for Gestational Age (SGA) | Drug: Genotropin (somatropin) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | October 2002 |
| Actual Primary Completion Date : | August 2015 |
| Actual Study Completion Date : | August 2015 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Genotropin (somatropin) |
Drug: Genotropin (somatropin)
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 |
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Month 12 (at the end of previous study) to 156 ]
- Height Velocity Standard Deviation Score (SDS) for Chronological Age [ Time Frame: 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 [ Time Frame: Month 12 (at the end of previous study) to 156 ]Height velocity is the yearly height gain
- Height SDS for Chronological Age [ Time Frame: 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 [ Time Frame: 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 SDS for Bone Age [ Time Frame: 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.
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| Ages Eligible for Study: | 4 Years to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859949
Show 19 study locations
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01859949 |
| Other Study ID Numbers: |
GENASG-0021-007 A6281225 ( Other Identifier: Alias Study Number ) 2015-004552-21 ( EudraCT Number ) |
| First Posted: | May 22, 2013 Key Record Dates |
| Results First Posted: | March 15, 2016 |
| Last Update Posted: | May 3, 2016 |
| Last Verified: | March 2016 |
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Genotropin(somatropin) SGA Short Stature Long-term Safety |
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Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Endocrine System Diseases |