CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Somatropindrug
Likely dose
Somatropin 12mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00601419
NCT00601419N/ACompleted
CompareCT.gov

Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Pfizer·observational·Posted Jan 28, 2008·Updated Feb 6, 2014

In Brief

An observational study evaluating Somatropin for Dwarfism, Growth Hormone Deficiency. Completed, enrolled 230 participants.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDwarfism, Growth Hormone Deficiency
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.4 years ago

Interventions

Somatropindrug

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.