Drug Use Investigation of Somatropin for GHD-ADULTS.

CompletedOBSERVATIONAL
Enrollment

230

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Dwarfism, Growth Hormone Deficiency
Interventions
DRUG

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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00601419 - Drug Use Investigation of Somatropin for GHD-ADULTS. | Biotech Hunter | Biotech Hunter