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| ID | Type | Description | Link |
|---|---|---|---|
| A6281225 | Other Identifier | Alias Study Number | |
| 2015-004552-21 | EudraCT Number |
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To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotropin (somatropin) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotropin (somatropin) | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Month 12 (at the end of previous study) to 156 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Occupational and Environmental Health Hospital | Kitakyushu | Fukuoka | 807-8555 | Japan | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Before enrolled this study, participants with short stature due to SGA had completed the 1-year(12-month) treatment in previous study.
Out of 62 participants who were enrolled this study, 61 participants were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-Increasing Group | Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day |
| FG001 | Dose-Remaining Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Month 12 (at the end of previous study) to 156 |
| Height Velocity | Height velocity is the yearly height gain | 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. | 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. | 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. | Month 12 (at the end of previous study) to 156 |
| Gunma University Hospital |
| Maebashi |
| Gunma |
| 371-8511 |
| Japan |
| Hiroshima City Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| Asahikawa Medical University Hospital | Asahikawa | Hokkaido | 078-8510 | Japan |
| Hokkaido Social Service Association Obihiro Hospital | Obihiro | Hokkaido | 080-0805 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Iwate Medical University Hospital | Morioka | Iwate | 020-8505 | Japan |
| Kitasato University Hospital | Sagamihara | Kanagawa | 252-0375 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka Medical Center and Research Institute for Maternal and Child Health | Izumi | Osaka | 594-1101 | Japan |
| Osaka Employees' Pension Hospital | Osaka | Osaka | 553-0003 | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Federal Officers' Mutual Aid Association Toranomon Hospital | Minato-ku | Tokyo | 105-8470 | Japan |
| National Center for Child Health and Development | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Tottori University Hospital | Yonago | Tottori | 683-8504 | Japan |
| Yamanashi University Hospital | Chūō | Yamanashi | 409-3898 | Japan |
Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose-Increasing Group | Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day |
| BG001 | Dose-Remaining Group | Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Number | participant | Month 12 (at the end of previous study) to 156 |
|
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Mean | Standard Deviation | SDS | Month 12 (at the end of previous study) to 156 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Height Velocity | Height velocity is the yearly height gain | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Mean | Standard Deviation | cm/year | Month 12 (at the end of previous study) to 156 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Mean | Standard Deviation | SDS | Month 12 (at the end of previous study) to 156 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Mean | Standard Deviation | SDS | Month 12 (at the end of previous study) to 156 |
| |||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study. | Posted | Mean | Standard Deviation | SDS | Month 12 (at the end of previous study) to 156 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-Increasing Group | Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day | 10 | 29 | 27 | 29 | ||
| EG001 | Dose-Remainig Group | Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study | 5 | 32 | 31 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RETINAL DETACHMENT | Eye disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| GASTROENTERITIS | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ADENOID HYPERTROPHY | Endocrine disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| UPPER RESP TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HERNIA INGUINAL | Reproductive system and breast disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| OVARIAN DISORDER | Reproductive system and breast disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HYPOSPADIAS | Congenital, familial and genetic disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| CRYPTORCHISM | Congenital, familial and genetic disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFECTION VIRAL | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HEALING IMPAIRED | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFLICTED INJURY | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACNE | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| RASH PUSTULAR | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SKIN DISORDER | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| OTITIS EXTERNA | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| BULLOUS ERUPTION | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| VERRUCA | Skin and subcutaneous tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| EYE ABNORMALITY | Eye disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| MYOPIA | Eye disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| GASTROENTERITIS | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| TOOTH CARIES | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| TOOTH DISORDER | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SGOT INCREASED | Hepatobiliary disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SGPT INCREASED | Hepatobiliary disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| GLUCOSE TOLERANCE ABNORMAL | Metabolism and nutrition disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SIALOADENITIS | Endocrine disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HYPOTENSION POSTURAL | Cardiac disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| COUGHING | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| RHINITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SINUSITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| UPPER RESP TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| EOSINOPHILIA | Blood and lymphatic system disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| LYMPHOCYTES ATYPICA | Blood and lymphatic system disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PURPURA | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HAEMATOMA | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| OVARIAN DISORDER | Reproductive system and breast disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SKELETAL MALFORMATION | Congenital, familial and genetic disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| TOOTH MALFORMATION | Congenital, familial and genetic disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ALLERGIC REACTION | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| FEVER | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| PAIN | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFLUENZA-LIKE SYMPTOMS | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INJECTION SITE BLEEDING | Injury, poisoning and procedural complications | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFECTION BACTERIAL | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFECTION VIRAL | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | WHO-ART, 2001(014) | Systematic Assessment |
| |
| VARICELLA | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| INFLICTED INJURY | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| MOLLUSCUM CONTAGIOSUM | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| SCOLIOSIS | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| LACERATION | General disorders | WHO-ART, 2001(014) | Systematic Assessment |
| |
| STING | Injury, poisoning and procedural complications | WHO-ART, 2001(014) | Systematic Assessment |
|
Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
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