Drug Use Investigation of Somatropin for GHD-ADULTS.
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Drug Use Investigation of GENOTROPIN for GHD-ADULTS.|
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- The incidence of adverse drug reactions. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- This study is a non-interventional/observational study and does not have any secondary outcomes measures. [ Time Frame: There are no secondary outcomes for this study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Patients administered 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.
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.