CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 920 enrolled
Drug / intervention
Somatropindrug
Likely dose
Somatropin 5.3mgfrom 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/NCT00793325
NCT00793325N/ACompleted
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Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)

Pfizer·observational·Posted Nov 19, 2008·Updated Feb 6, 2014

In Brief

An observational study evaluating Somatropin for Small for Gestational Age. Completed, enrolled 920 participants.

Detailed Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSmall for Gestational Age
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2008
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.6 years ago

Interventions

Somatropindrug

Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."