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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001020-36 | EudraCT Number |
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This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.
Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (height standard deviation score[SDS]<-2 below the mean for age and gender), low serum IGF-1 (IGF-1 SDS <-2 below the mean for age and gender), and levels of growth hormone (GH) that are normal (≥7ng/mL) after a GH stimulation test. Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH, i.e., a type of GH insensitivity or GH resistance.
This trial is one year, randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated | No Intervention | Observational Group | |
| 40 μg/kg BID (twice daily dosing) | Experimental | Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. |
|
| 80 μg/kg BID (twice daily dosing) | Experimental | Injection of rhIGF-1 80 μg/kg BID |
|
| 120 μg/kg BID (twice daily dosing) | Experimental | Injection of rhIGF-1 120 μg/kg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhIGF-1 (mecasermin, Tercica, Inc.) | Drug | Twice Daily Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height Velocity During the First Year - Intent to Treat (ITT)Population | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. | Measured at baseline and at one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen (formerly Tercica) | Brisbane | California | 94005 | United States |
Subject screening consisted of three staged clinic visits over 6 weeks, including a medical history, complete physical examination, IGF-1 measurements, a Growth Hormone (GH) stimulation test, and an IGF-1 generation test.
Study Initiation Date: 14 March 2004. Study completion Date: 02 July 2008. 44 investigators screened subjects; 14 did not enroll any subjects. 137 subjects were enrolled. Consent for one randomized subject was withdrawn prior to any study measurements. This subject was excluded from all analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Untreated | Observational Group |
| FG001 | 40 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. |
| FG002 | 80 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 80 μg/kg BID |
| FG003 | 120 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 120 μg/kg BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Untreated | Observational Group |
| BG001 | 40 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Height Velocity During the First Year - Intent to Treat (ITT)Population | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. | A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | cm/yr | Measured at baseline and at one year |
|
Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
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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 | Untreated | Observational Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cor Triatriatum | Congenital, familial and genetic disorders | MedDRA 11.00 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Pediatric Endocrinology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000604197 | mecasermin |
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| Measured at baseline and at one year |
| Changes in Bone Age From Baseline to One Year | Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation. | Measured at baseline and at one year |
| Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year | Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel. | Measured at baseline and at one year |
| Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year | Blood sample was collected for measuring the level of IGF-2 in the growth factor panel. | Measured at baseline and at one year |
| Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year | Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel. | Measured at baseline and at one year |
| Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year | Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel. | Measured at baseline and at one year |
| IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. | Study Day 1 and Day 7 |
| IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. | Study Day 1 and Day 7 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | 80 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 80 μg/kg BID |
| BG003 | 120 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 120 μg/kg BID |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Stratum | Please note that SD is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child. | Number | participants |
|
| Height Standard Deviation (SD) Score | Please note that SD is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child. | Mean | Standard Deviation | SD |
|
| IGF-1 Standard Deviation (SD) Score | Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. | Mean | Standard Deviation | SD |
|
| Maximum Stimulated Growth Hormone | Growth Hormone Stimulation Test results expressed in ng/mL | Mean | Standard Deviation | ng/mL |
|
| Weight | Mean | Standard Deviation | Kg |
|
| 40 μg/kg BID (Twice Daily Dosing) |
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. |
| OG002 | 80 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 80 μg/kg BID |
| OG003 | 120 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 120 μg/kg BID |
|
|
|
| Secondary | Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. | A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | SD/year | Measured at baseline and at one year |
|
|
|
|
| Secondary | Changes in Bone Age From Baseline to One Year | Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | Year | Measured at baseline and at one year |
|
|
|
| Secondary | Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year | Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | Percent change | Measured at baseline and at one year |
|
|
|
| Secondary | Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year | Blood sample was collected for measuring the level of IGF-2 in the growth factor panel. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | Percent change | Measured at baseline and at one year |
|
|
|
| Secondary | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year | Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | Percent change | Measured at baseline and at one year |
|
|
|
| Secondary | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year | Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | Percent change | Measured at baseline and at one year |
|
|
|
| Secondary | IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | ng/mL | Study Day 1 and Day 7 |
|
|
|
| Secondary | IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | mg/dL | Study Day 1 and Day 7 |
|
|
|
| Post-Hoc | Height Velocity During the First Year for Subjects - Completers | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. | All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | cm/year | One Year |
|
|
|
|
| Post-Hoc | Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers | Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child. | All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Posted | Mean | Standard Deviation | SD/year | One Year |
|
|
|
|
| 1 |
| 25 |
| 18 |
| 25 |
| EG001 | 40 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. | 1 | 16 | 16 | 16 |
| EG002 | 80 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 80 μg/kg BID | 2 | 44 | 37 | 44 |
| EG003 | 120 μg/kg BID (Twice Daily Dosing) | Injection of rhIGF-1 120 μg/kg BID | 5 | 51 | 43 | 51 |
| Hypoglycemic seizure | Endocrine disorders | MedDRA 11.00 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 11.00 | Non-systematic Assessment |
|
| Gastroenteritis escherichia coli | Gastrointestinal disorders | MedDRA 11.00 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.00 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Benign Itracranial Hypertension | Nervous system disorders | MedDRA 11.00 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 11.00 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 11.00 | Systematic Assessment | In order to avoid under-reporting hypoglycemia, transient symptoms with no accompanying blood glucose measurements were also reported as "hypoglycemia" or "hypoglycemia/decreased blood glucose". |
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| Gastroenteritis viral | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Ear infection | Ear and labyrinth disorders | MedDRA 11.00 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 11.00 | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 11.00 | Non-systematic Assessment |
|
Each investigator may publish or report data from their own subjects. The trial data in aggregate are the property of Tercica, Inc. and may not be published without permission of Tercica, Inc. Tercica, Inc. will be the final arbitrator of issues relating to the publication or presentation of the aggregate data.
| The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | < 0.0001 | The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method. | LS mean difference | 0.47 | Standard Error of the Mean | 0.06 | 95 | 0.34 | 0.60 | Superiority or Other (legacy) |
| The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | 0.0495 | LS mean difference | 0.11 | Standard Error of the Mean | 0.05 | 95 | 0.00 | 0.22 | Superiority or Other (legacy) |
| The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | <0.0001 | The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method. | LS mean difference | 2.83 | Standard Error of the Mean | 0.29 | 95 | 2.26 | 3.39 | Superiority or Other (legacy) |
| The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | 0.0002 | LS mean difference | 1.01 | Standard Error of the Mean | 0.25 | 95 | 0.50 | 1.51 | Superiority or Other (legacy) |
| The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | <0.0001 | The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method. | LS mean difference | 0.52 | Standard Error of the Mean | 0.06 | 95 | 0.39 | 0.64 | Superiority or Other (legacy) |
| The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex. | ANCOVA | 0.0071 | LS mean difference | 0.15 | Standard Error of the Mean | 0.06 | 95 | 0.04 | 0.26 | Superiority or Other (legacy) |