Completed
OBSERVATIONAL
NCT00601419
Drug Use Investigation of Somatropin for GHD-ADULTS.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
Detailed Description
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
Interventions
Name:
Somatropin
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Number of Participants With Treatment Related Adverse Events.
TimeFrame:
6 month
Description:
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.
Measure:
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
TimeFrame:
6 month
Description:
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.
Measure:
Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
TimeFrame:
6 month
Description:
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Measure:
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
TimeFrame:
6 month
Description:
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Measure:
Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.
TimeFrame:
6 month
Description:
To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.
Measure:
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
TimeFrame:
6 month
Description:
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Measure:
Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.
TimeFrame:
6 month
Description:
To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.
Measure:
Proportion of Participants Achieving Clinical Efficacy.
TimeFrame:
6 month
Description:
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.
Measure:
Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.
TimeFrame:
6 month
Description:
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.
Measure:
Proportion of Participants Achieving Clinical Efficacy by Gender.
TimeFrame:
6 month
Description:
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.
Measure:
Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.
TimeFrame:
6 month
Description:
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.
Trial Information
NCT ID
NCT00601419
Status
Completed
Study Type
OBSERVATIONAL
Sponsor
Pfizer
Last Updated
December 15, 2025