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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1125-4790 | Other Identifier | WHO | |
| 2015-002613-30 | EudraCT Number |
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This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hGH:12months treatment | Experimental |
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| hGH: 6 month un-treatment + 6 month treatment | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Height Velocity (Ht-V) | Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk. | After 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ht-SDS (Height Standard Deviation Score) | Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal. | After 6 months of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Busan | 614-735 | South Korea | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Safety and Efficacy Evaluation of Human Growth Hormone (GH) Therapy in Patients with Idiopathic Short Stature (ISS) in Korea - a Randomized Controlled Trial; Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko et al.; 028-042-GH-Pediatrics (posters) ENDO meeting 2016, Boston Massachusetts | ||
| 32595770 | Derived | Jung MH, Suh BK, Ko CW, Lee KH, Jin DK, Yoo HW, Hwang JS, Chung WY, Han HS, Prusty V, Kim HS. Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial. Eur Endocrinol. 2020 Apr;16(1):54-59. doi: 10.17925/EE.2020.16.1.54. Epub 2019 Oct 15. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The trial was conducted at 10 sites in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 12-month GH Treatment | For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. |
| FG001 | Group B: 6-month Untreated + 6-month GH Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) | IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated. | After 6 months of treatment. |
| Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) | IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated. | After 6 months of treatment. |
| Change in Bone Age | Change in bone age from the baseline to 6 months. | After 6 months of treatment. |
| Occurrence of Adverse Events | AEs were collected throughout the trial in both groups. | Throughout the trial (12 months) |
| Ht-V (Height Velocity) | Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol. | At the first 6 months and the last 6 months in group A |
| Daegu |
| 700-721 |
| South Korea |
| Novo Nordisk Investigational Site | Seoul | 02841 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 03722 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 137-701 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 138-736 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 150-713 | South Korea |
| Novo Nordisk Investigational Site | Suwon | 443-721 | South Korea |
Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 12-month GH Treatment | For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. |
| BG001 | Group B: 6-month Untreated + 6-month GH Treatment | Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | N=32, 15 due to missing baseline values for this characteristics. | Mean | Standard Deviation | cm |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Height Velocity (Ht-V) | Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk. | Full analysis set (FAS) - included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit. | Posted | Least Squares Mean | Standard Error | cm/year | After 6 months of treatment |
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| Secondary | Change in Ht-SDS (Height Standard Deviation Score) | Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal. | Full analysis set (FAS) - included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit. | Posted | Least Squares Mean | Standard Error | Standard Deviation Score (SDS) | After 6 months of treatment. |
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| Secondary | Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) | IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated. | Full analysis set (FAS) - included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. | Posted | Least Squares Mean | Standard Error | ng/ml | After 6 months of treatment. |
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| Secondary | Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) | IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated. | Full analysis set (FAS) - included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. | Posted | Least Squares Mean | Standard Error | mcg/mL | After 6 months of treatment. |
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| Secondary | Change in Bone Age | Change in bone age from the baseline to 6 months. | Safety analysis set (SAS) :includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2. | Posted | Mean | Standard Deviation | years | After 6 months of treatment. |
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| Secondary | Occurrence of Adverse Events | AEs were collected throughout the trial in both groups. | Safety analysis set - includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2. | Posted | Number | events | Throughout the trial (12 months) |
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| Secondary | Ht-V (Height Velocity) | Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol. | Full analysis set (FAS) - included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. | Posted | Least Squares Mean | 95% Confidence Interval | cm/year | At the first 6 months and the last 6 months in group A |
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Safety analysis set - includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.
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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 | Group A: 12-month GH Treatment | For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. | 4 | 36 | 20 | 36 | ||
| EG001 | Group B: 6-month Untreated + 6-month GH Treatment | Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®. | 2 | 15 | 10 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA (18.0) | Systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Kawasaki's disease | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorder | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Upper respiratory tract | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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Novo Nordisk reserves the right to not release data until specified milestones, e.g. when the clinical trial report is available. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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