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| ID | Type | Description | Link |
|---|---|---|---|
| A6281024 |
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See termination reason in detailed description.
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This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Liquid, daily to final height Maximum Dosage: 50 µg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 3 |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, final height (assessed up to Year 9.5) |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 3 |
| Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | |
| Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29029101 | Derived | David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants included in previous study CTN 97-8129-016 were eligible for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin (With Previous Somatropin Exposure) | Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| FG001 | Somatropin (Without Previous Somatropin Exposure) | Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin (With Previous Somatropin Exposure) | Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Full Range | SDS | Baseline, Year 3 |
|
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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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Somatropin (With Previous Somatropin Exposure) | Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
Data for bone mineral density (BMD), bone mineral content (BMC) and IGFBP3 were not analyzed because of change in planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
Not provided
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 |
Not provided
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| Baseline, final height (assessed up to Year 9.5) |
| Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 3 |
| Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, final height (assessed up to Year 9.5) |
| Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
| Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan. | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
| Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| BG001 | Somatropin (Without Previous Somatropin Exposure) | Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
| OG001 | Somatropin (Without Previous Somatropin Exposure) | Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. |
|
|
| Primary | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | Data was not analyzed because of change in planned analysis after early termination of the study. | Posted | Baseline, final height (assessed up to Year 9.5) |
|
|
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Full Range | SDS | Baseline, Year 3 |
|
|
|
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Full Range | SDS | Baseline, final height (assessed up to Year 9.5) |
|
|
|
| Primary | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Full Range | SDS | Baseline, Year 3 |
|
|
|
| Primary | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Median | Full Range | SDS | Baseline, final height (assessed up to Year 9.5) |
|
|
|
| Secondary | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | Posted | Median | Full Range | milligram per deciliter (mg/dL) | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
|
|
|
| Secondary | Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study. | Posted | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
|
|
| Secondary | Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan. | Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study. | Posted | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 |
|
|
| Secondary | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | Posted | Median | Full Range | grams | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 |
|
|
|
| Secondary | Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | Posted | Median | Full Range | SDS | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
|
|
|
| Secondary | Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | Posted | Median | Full Range | mg | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 |
|
|
|
| 6 |
| 11 |
| 11 |
| 11 |
| EG001 | Somatropin (Without Previous Somatropin Exposure) | Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls. | 2 | 10 | 9 | 10 |
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Leishmaniasis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Relapsing fever | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Osteochondritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrostomy closure | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Congenital scoliosis | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sigmoiditis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Nail candida | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Glucose tolerance test | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyperinsulinaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insulin resistance | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Enuresis | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypercalciuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lividity | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Walking disability | Social circumstances | MedDRA 14.1 | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Poor peripheral circulation | Vascular disorders | MedDRA 14.1 | Non-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.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Change at Year 1 (n = 11, 10) |
|
| Change at Year 1.5 (n = 11, 9) |
|
| Change at Year 2 (n = 10, 9) |
|
| Change at Year 2.5 (n = 8, 8) |
|
| Change at Year 3 (n = 7, 9) |
|
| Change at Year 3.5 (n = 7, 7) |
|
| Change at Year 4 (n = 6, 7) |
|
| Change at Year 4.5 (n = 5, 6) |
|
| Change at Year 5 (n = 5, 7) |
|
| Change at Year 5.5 (n = 4, 5) |
|
| Change at Year 6 (n = 4, 5) |
|
| Change at Year 6.5 (n = 2, 5) |
|
| Change at Year 7 (n = 1, 5) |
|
| Change at Year 7.5 (n = 0, 3) |
|
| Change at Year 8 (n = 0, 2) |
|
| Change at Year 8.5 (n = 0, 1) |
|
| Change at Year 9 (n = 2, 1) |
|
| Change at Year 2 (n = 10, 9) |
|
| Change at Year 3 (n = 7, 8) |
|
| Change at Year 4 (n = 4, 3) |
|
| Change at Year 5 (n = 4, 7) |
|
| Change at Year 6 (n = 4, 5) |
|
| Change at Year 7 (n = 1, 5) |
|
| Change at Year 8 (n = 0, 2) |
|
| Change at Year 9 (n = 2, 1) |
|
| Change at Year 1 (n = 11, 10) |
|
| Change at Year 1.5 (n = 11, 9) |
|
| Change at Year 2 (n = 10, 9) |
|
| Change at Year 2.5 (n = 8, 8) |
|
| Change at Year 3 (n = 7, 9) |
|
| Change at Year 3.5 (n = 7, 7) |
|
| Change at Year 4 (n = 6, 7) |
|
| Change at Year 4.5 (n = 5, 6) |
|
| Change at Year 5 (n = 5, 7) |
|
| Change at Year 5.5 (n = 3, 5) |
|
| Change at Year 6 (n = 3, 5) |
|
| Change at Year 6.5 (n = 2, 5) |
|
| Change at Year 7 (n = 1, 5) |
|
| Change at Year 7.5 (n = 0, 3) |
|
| Change at Year 8 (n = 0, 2) |
|
| Change at Year 8.5 (n = 0, 1) |
|
| Change at Year 9 (n = 1, 1) |
|
| Change at Year 1 (n = 11, 9) |
|
| Change at Year 1.5 (n = 11, 8) |
|
| Change at Year 2 (n = 10, 8) |
|
| Change at Year 2.5 (n = 8, 7) |
|
| Change at Year 3 (n = 7, 7) |
|
| Change at Year 3.5 (n = 7, 6) |
|
| Change at Year 4 (n = 6, 7) |
|
| Change at Year 4.5 (n = 5, 6) |
|
| Change at Year 5 (n = 5, 7) |
|
| Change at Year 5.5 (n = 4, 5) |
|
| Change at Year 6 (n = 4, 5) |
|
| Change at Year 6.5 (n = 2, 5) |
|
| Change at Year 7 (n = 1, 5) |
|
| Change at Year 7.5 (n = 0, 3) |
|
| Change at Year 8 (n = 0, 2) |
|
| Change at Year 8.5 (n = 0, 1) |
|
| Change at Year 9 (n = 2, 1) |
|