Drug Use Investigation of Somatropin for GHD-ADULTS.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-12-31

Brief Summary

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Post marketing drug use investigation of Genotropin for GHD-ADULTS.

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Detailed Description

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All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.

Conditions

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Dwarfism, Growth Hormone Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Somatropin

Patients administered Somatropin.

Somatropin

Intervention Type 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.

Interventions

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Somatropin

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.

Intervention Type DRUG