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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003949-32 | EudraCT Number | ||
| SGA | Other Identifier | Alias Study Number |
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To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | The active treatment arm |
|
| Control | Experimental | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotropin (PN-180,307) Somatropin | Drug | Injectable Genotropin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Growth Velocity SDS at Month 24. | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. |
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Inclusion Criteria:
Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.
Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).
Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.
Exclusion Criteria:
Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).
Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.
Defined neurological defects and/or severe neurodevelopmental delay.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel/Pediatrie | Brussels | 1090 | Belgium | |||
| Universitair Ziekenhuis Antwerpen / Pediatrie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26501737 | Derived | De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(R)) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants aged between 19 to 29 months at Screening visit, born SGA (birth length and/or weight <-2 standard deviations (SD) for gestational age, using country-specific standards), height below -2.5 SD at Screening (19-29 months of age), and had at least one measurement of length between 12 and 18 months of age were enrolled in this study.
This randomized controlled trial enrolled small for gestational age (SGA) children at 16 centers in 8 countries. In total, 52 participants were screened for the study, of these, 9 participants were considered screen failures. The remaining 43 participants were randomized to receive either study drug (Genotropin®) or were not treated (Control).
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotropin® | Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Control-no treatment |
| Drug |
Control-no treatment |
|
| Baseline and Month 24 |
| Change From Baseline in Height SDS at Month 12. | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Baseline and Month 12 |
| Change From Baseline in Growth Velocity SDS at Month 12. | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. | Baseline and Month 12 |
| Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. | Baseline and Month 12 |
| Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. | BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. | Baseline and Month 12 |
| Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. | Months 3, 6, 12, 18 and 24 |
| Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. | Baseline, Months 3, 6, 12, 18 and 24. |
| Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. | Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. | Baseline, Months 3, 6, 12, 18, and 24 |
| Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. | Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. | Baseline, Months 3, 6, 12, 18, and 24 |
| Edegem |
| 2650 |
| Belgium |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Ostrava, Detska klinika | Ostrava-Poruba | 708 52 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| CHU Toulouse, Hôpital des Enfants, Service Endocrinologie | Toulouse | 31059 | France |
| Universitaetsklinikum Erlangen, Kinder- und Jugendklinik | Erlangen | 91054 | Germany |
| Centro di Endocrinologia Pediatrica, Dipartimento di Pediatria | Catania | 95125 | Italy |
| Policlinico Universitario, Istituto di Clinica Pediatrica | Messina | 98100 | Italy |
| Dipartimento Materno Infantile, UO di Pediatria e Neonatologia | Milan | 20132 | Italy |
| Dipartimento di Medicina Pediatrica, UO di Endocrinologia e Diabetologia | Roma | 00165 | Italy |
| Sophia Children's Hospital | Rotterdam | 3015 GJ | Netherlands |
| Consorci Hospitalari Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Virgen Del Camino | Pamplona | Navarre | 31008 | Spain |
| Hospital Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| Drottning Silvias Barn och Ungdomssjukhus | Gothenburg | Sweden |
| Inselspital | Ch-3010 Bern | Switzerland |
| FG001 | Control | This group was the untreated control group and was not administered placebo. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotropin® | Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization. |
| BG001 | Control | This group was the untreated control group and was not administered placebo. |
| 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 | Months |
| |||||||||||||||
| 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 | Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | Posted | Least Squares Mean | Standard Error | SDS | Baseline and Month 24 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Growth Velocity SDS at Month 24. | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | Posted | Least Squares Mean | Standard Error | SDS | Baseline and Month 24 |
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| Secondary | Change From Baseline in Height SDS at Month 12. | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | Posted | Least Squares Mean | Standard Error | SDS | Baseline and Month 12 |
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| Secondary | Change From Baseline in Growth Velocity SDS at Month 12. | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | Posted | Least Squares Mean | Standard Error | SDS | Baseline and Month 12 |
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| Secondary | Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Month 12 |
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| Secondary | Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. | BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Month 12 |
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| Secondary | Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Mean | Standard Deviation | SDS | Months 3, 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Mean | Standard Deviation | SDS | Baseline, Months 3, 6, 12, 18 and 24. |
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| Secondary | Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. | Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Mean | Standard Deviation | Kg | Baseline, Months 3, 6, 12, 18, and 24 |
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| Secondary | Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. | Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Posted | Mean | Standard Deviation | Kg/m2 | Baseline, Months 3, 6, 12, 18, and 24 |
|
Up to the participant's age of 49 to 55 months (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genotropin® | Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization. | 6 | 21 | 21 | 21 | ||
| EG001 | Control | This group was the untreated control group and was not administered placebo. | 2 | 22 | 18 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conductive deafness | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear disorder | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchial dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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 |
|---|---|
| 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
| Male |
|
| Superiority or Other |
| OG001 | Control | This group was the untreated control group and was not administered placebo. |
|
|
|
| Control |
This group was the untreated control group and was not administered placebo. |
|
|
|
| OG001 | Control | This group was the untreated control group and was not administered placebo. |
|
|
|
| OG001 |
| Control |
This group was the untreated control group and was not administered placebo. |
|
|
|
| Control |
This group was the untreated control group and was not administered placebo. |
|
|
|
This group was the untreated control group and was not administered placebo.
|
|
This group was the untreated control group and was not administered placebo.
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|