A Phase 4 interventional study of Genotropin (somatropin) in Short Stature Born Small for Gestational Age (SGA), sponsored by Pfizer. Completed at 19 sites in Japan. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
129 studies on the registry are indexed under Dwarfism; 19 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 78 interventional studies indexed under Dwarfism.
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Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
Exclusion Criteria:
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
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
Height Velocity
Height velocity is the yearly height gain
Time frame: Month 12 (at the end of previous study) to 156
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.
Time frame: Month 12 (at the end of previous study) to 156
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.
Time frame: Month 12 (at the end of previous study) to 156
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.
Time frame: Month 12 (at the end of previous study) to 156
| Milestone | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Started | 29 | 32 |
| Completed | 15 | 15 |
| Not completed | 14 | 17 |
| Withdrew: Family matters | 0 | 1 |
| Withdrew: Physician decision | 2 | 4 |
| Withdrew: Withdrawal by subject | 11 | 10 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| participant | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| AE | 27 | 31 |
| SAE | 10 | 5 |
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.
| SDS | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Month 12 to 24 (Increasing: n=28, Remaining: n=32) | 2.782 ± 1.978 | 2.595 ± 1.731 |
| Month 24 to36 (Increasing:n=26, Remaining:n=28) | 1.812 ± 1.526 | 1.696 ± 2.111 |
| Month 36 to 48 (Increasing: n=24, Remaining: n=23) | 1.480 ± 1.543 | 0.824 ± 1.527 |
| Month 48 to 60 (Increasing: n=21, Remaining: n=20) | -0.041 ± 2.081 | 0.480 ± 1.651 |
| Month 60 to 72 (Increasing: n=20, Remaining: n=16) | -0.293 ± 1.585 | -0.046 ± 2.434 |
| Month 72 to 84 (Increasing: n=15, Remaining: n=16) | -0.488 ± 3.117 | -1.511 ± 2.692 |
| Month 84 to 96 (Increasing: n=11, Remaining: n=14) | 0.263 ± 1.802 | -0.114 ± 1.964 |
| Month 96 to 108 (Increasing: n=9, Remaining: n=8) | 0.521 ± 2.058 | -0.466 ± 2.055 |
| Month 108 to 120 (Increasing: n=6, Remaining: n=6) | -0.668 ± 2.126 | -0.590 ± 2.693 |
| Month 120 to 132 (Increasing: n=5, Remaining: n=4) | -1.080 ± 1.953 | 1.173 ± 3.042 |
| Month 132 to 144 (Increasing: n=4, Remaining: n=2) | 2.655 ± 4.329 | 0.730 ± 2.022 |
| Month 144 to 156 (Increasing: n=3, Remaining: n=0) | 3.373 ± 1.995 | NA ± NA |
Height velocity is the yearly height gain
| cm/year | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Month 12 to 24 (Increasing: n=28, Remaining: n=32) | 7.83 ± 1.33 | 7.70 ± 1.19 |
| Month 24 to 36 (Increasing: n=26, Remaining: n=28) | 6.88 ± 0.94 | 6.75 ± 1.52 |
| Month 36 to 48 (Increasing: n=24, Remaining: n=23) | 6.68 ± 0.98 | 6.08 ± 1.14 |
| Month 48 to 60 (Increasing: n=21, Remaining: n=20) | 6.06 ± 1.49 | 6.30 ± 1.24 |
| Month 60 to 72 (Increasing: n=20, Remaining: n=16) | 6.08 ± 1.45 | 6.49 ± 1.37 |
| Month 72 to 84 (Increasing: n=15, Remaining: n=16) | 4.89 ± 2.18 | 4.88 ± 1.86 |
| Month 84 to 96 (Increasing: n=11, Remaining: n=14) | 5.16 ± 1.20 | 4.82 ± 2.12 |
| Month 96 to 108 (Increasing: n=9, Remaining: n=8) | 5.18 ± 2.16 | 5.55 ± 2.42 |
| Month 108 to 120 (Increasing: n=6, Remaining: n=6) | 5.72 ± 2.24 | 5.03 ± 1.86 |
| Month 120 to 132 (Increasing: n=5, Remaining: n=4) | 4.84 ± 1.30 | 4.30 ± 1.84 |
| Month 132 to 144 (Increasing: n=4, Remaining: n=2) | 4.38 ± 1.10 | 2.60 ± 0.14 |
| Month 144 to 156(Increasing: n=3, Remaining: n=0) | 3.10 ± 1.92 | NA ± NA |
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.
| SDS | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Month 12 (Increasing: n=29, Remaining: n=32) | -2.53 ± 0.92 | -2.17 ± 0.96 |
| Month 24 (Increasing: n=28, Remaining: n=32) | -2.02 ± 0.97 | -1.70 ± 1.03 |
| Month 36 (Increasing: n=26, Remaining: n=28) | -1.80 ± 0.99 | -1.53 ± 1.10 |
| Month 48 (Increasing: n=24, Remaining: n=23) | -1.48 ± 1.05 | -1.49 ± 1.15 |
| Month 60 (Increasing: n=21, Remaining: n=20) | -1.53 ± 1.06 | -1.44 ± 1.10 |
| Month 72 (Increasing: n=20, Remaining: n=16) | -1.56 ± 1.11 | -1.43 ± 1.06 |
| Month 84 (Increasing: n=15, Remaining: n=16) | -1.73 ± 1.13 | -1.58 ± 1.17 |
| Month 96 (Increasing: n=11, Remaining: n=14) | -1.52 ± 0.89 | -1.87 ± 1.36 |
| Month 108 (Increasing: n=9, Remaining: n=8) | -1.52 ± 1.01 | -1.63 ± 1.48 |
| Month 120 (Increasing: n=6, Remaining: n=6) | -1.52 ± 1.20 | -1.25 ± 0.59 |
| Month 132 (Increasing: n=5, Remaining: n=4) | -1.96 ± 1.11 | -0.98 ± 0.51 |
| Month 144 (Increasing: n=4, Remaining: n=2) | -1.73 ± 0.87 | -0.70 ± 0.42 |
| Month 156 (Increasing: n=3, Remaining: n=0) | -1.77 ± 0.76 | NA ± NA |
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.
| SDS | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Month 12 to 24 (Increasing: n=26, Remaining: n=31) | 2.586 ± 2.268 | 2.461 ± 1.990 |
| Month 24 to 36 (Increasing: n=24, Remaining: n=27) | 1.503 ± 1.830 | 1.091 ± 1.852 |
| Month 36 to 48 (Increasing: n=22, Remaining: n=22) | 1.196 ± 1.409 | 0.510 ± 1.809 |
| Month 48 to 60 (Increasing: n=20, Remaining: n=19) | -0.062 ± 1.775 | 0.913 ± 2.146 |
| Month 60 to 72 (Increasing: n=16, Remaining: n=14) | 0.281 ± 2.814 | 0.949 ± 2.729 |
| Month 72 to 84 (Increasing: n=13, Remaining: n=13) | -1.249 ± 2.558 | 0.932 ± 2.545 |
| Month 84 to 96 (Increasing: n=10, Remaining: n=13) | 0.804 ± 3.440 | 0.286 ± 2.351 |
| Month 96 to 108 (Increasing: n=8, Remaining: n=7) | -0.634 ± 2.419 | -0.223 ± 1.352 |
| Month 108 to 120 (Increasing: n=5, Remaining: n=5) | 0.070 ± 4.120 | 0.532 ± 1.809 |
| Month 120 to 132 (Increasing: n=4, Remaining: n=4) | 1.553 ± 3.019 | 2.718 ± 0.864 |
| Month 132 to 144 (Increasing: n=3, Remaining: n=2) | 2.310 ± 1.711 | 2.185 ± 0.304 |
| Month 144 to 156 (Increasing: n=2, Remaining: n=0) | 2.710 ± 2.942 | NA ± NA |
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.
| SDS | Dose-Increasing Group | Dose-Remaining Group |
|---|---|---|
| Month 12 (Increasing: n=27, Remaining: n=31) | -1.19 ± 1.20 | -0.68 ± 1.54 |
| Month 24 (Increasing: n=26, Remaining: n=31) | -1.15 ± 1.15 | -0.88 ± 1.79 |
| Month 36 (Increasing: n=24, Remaining: n=27) | -1.20 ± 1.35 | -1.17 ± 1.62 |
| Month 48 (Increasing: n=22, Remaining: n=22) | -0.74 ± 1.32 | -1.46 ± 1.01 |
| Month 60 (Increasing: n=20, Remaining: n=19) | -1.16 ± 1.21 | -1.80 ± 0.97 |
| Month 72 (Increasing: n=16, Remaining: n=14) | -1.78 ± 1.02 | -1.70 ± 0.77 |
| Month 84 (Increasing: n=13, Remaining: n=13) | -1.85 ± 1.17 | -2.15 ± 0.92 |
| Month 96 (Increasing: n=10, Remaining: n=13) | -1.77 ± 1.12 | -2.27 ± 1.06 |
| Month 108 (Increasing: n=8, Remaining: n=7) | -1.41 ± 0.97 | -1.94 ± 1.37 |
| Month 120 (Increasing: n=5, Remaining: n=5) | -1.58 ± 1.50 | -1.38 ± 0.98 |
| Month 132 (Increasing: n=4, Remaining: n=4) | -2.10 ± 1.21 | -0.98 ± 0.74 |
| Month 144 (Increasing: n=3, Remaining: n=2) | -1.40 ± 0.17 | -0.65 ± 0.64 |
| Month 156 (Increasing: n=2, Remaining: n=0) | -1.55 ± 0.92 | NA ± NA |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose-Increasing Group | — | 10/29 (34.5%) | 27/29 (93.1%) |
| Dose-Remainig Group | — | 5/32 (15.6%) | 31/32 (96.9%) |
| Event | Dose-Increasing Group | Dose-Remainig Group |
|---|---|---|
| GASTROENTERITISGastrointestinal disorders | 2/29 | 0/32 |
| ADENOID HYPERTROPHYEndocrine disorders | 1/29 | 2/32 |
| PHARYNGITISRespiratory, thoracic and mediastinal disorders | 1/29 | 2/32 |
| DEAFNESSEar and labyrinth disorders | 1/29 | 0/32 |
| HEPATIC FUNCTION ABNORMALHepatobiliary disorders | 1/29 | 0/32 |
| PNEUMONIARespiratory, thoracic and mediastinal disorders | 1/29 | 0/32 |
| UPPER RESP TRACT INFECTIONRespiratory, thoracic and mediastinal disorders | 1/29 | 0/32 |
| BRONCHITISRespiratory, thoracic and mediastinal disorders | 1/29 | 0/32 |
| ASTHMARespiratory, thoracic and mediastinal disorders | 1/29 | 0/32 |
| HERNIA INGUINALReproductive system and breast disorders | 1/29 | 1/32 |
| Event | Dose-Increasing Group | Dose-Remainig Group |
|---|---|---|
| UPPER RESP TRACT INFECTIONRespiratory, thoracic and mediastinal disorders | 25/29 | 28/32 |
| GASTROENTERITISGastrointestinal disorders | 17/29 | 10/32 |
| INFLUENZA-LIKE SYMPTOMSGeneral disorders | 16/29 | 15/32 |
| OTITIS MEDIAInfections and infestations | 13/29 | 14/32 |
| FEVERGeneral disorders | 11/29 | 1/32 |
| CONJUNCTIVITISEye disorders | 8/29 | 12/32 |
| RHINITISRespiratory, thoracic and mediastinal disorders | 8/29 | 12/32 |
| BRONCHITISRespiratory, thoracic and mediastinal disorders | 9/29 | 10/32 |
| PHARYNGITISRespiratory, thoracic and mediastinal disorders | 7/29 | 9/32 |
| ECZEMASkin and subcutaneous tissue disorders | 6/29 | 5/32 |
| Age, Continuous(years) | Dose-Increasing Group | Dose-Remaining Group | Total |
|---|---|---|---|
| Mean | 5.20 ± 1.64 | 5.40 ± 1.27 | 5.31 ± 1.45 |
| Sex: Female, Male(Participants) | Dose-Increasing Group | Dose-Remaining Group | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 15 | 18 | 33 |
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Studies of the drug tested here: Human Growth Hormone