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Post marketing drug use investigation of Genotropin for GHD-ADULTS.
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Patients administered Somatropin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg. Dosage, Frequency: According to Japanese LPD, "The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day". Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. | 6 month |
| Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert. | 6 month |
| Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. | To determine whether age is a significant risk factor in the frequency of treatment related adverse events. | 6 month |
| Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. | To determine whether gender is a significant risk factor in the frequency of treatment related adverse events. | 6 month |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. | To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events. |
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Inclusion Criteria:
The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
Exclusion Criteria:
Patients not administered Somatropin.
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The patients whom an investigator involving A6281286 prescribes the Somatropin.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19479077 | Derived | Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS One. 2009 May 22;4(5):e5668. doi: 10.1371/journal.pone.0005668. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin | Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin | Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Events. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
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The frequency of treatment related adverse events.
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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 | Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-J 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA-J 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
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|
| 6 month |
| Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. | To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events. | 6 month |
| Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. | To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events. | 6 month |
| Proportion of Participants Achieving Clinical Efficacy. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month |
| Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month |
| Proportion of Participants Achieving Clinical Efficacy by Gender. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month |
| Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | 6 month |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | events | 6 month |
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. | To determine whether age is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. | To determine whether gender is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. | To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. | To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. | To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events. | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Proportion of Participants Achieving Clinical Efficacy. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction. | Posted | Number | participants | 6 month |
|
|
|
| Primary | Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Proportion of Participants Achieving Clinical Efficacy by Gender. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction. | Posted | Number | participants | 6 month |
|
|
|
|
| Primary | Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. | Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables. | The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction. | Posted | Number | participants | 6 month |
|
|
|
|
| 10 |
| 226 |
| 19 |
| 226 |
| Craniopharyngioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-J 15.0 | Systematic Assessment |
|
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-J 15.0 | Systematic Assessment |
|
| Germ cell cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-J 15.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA-J 15.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA-J 15.0 | Systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA-J 15.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA-J 15.0 | 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.
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
The risk factor tested was "Initial Dose". The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose. |
| Cochran-Armitage Exact |
| =0.063 |
| 2-Sided |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|