Long Term Use of Somatropin in Patients Small for Gestational Age

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

920 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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All the patients whom an investigator prescribes the first Genotropin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions

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Small for Gestational Age

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® 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."

Interventions

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Somatropin

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."

Intervention Type DRUG