Overview

This trial is active, not recruiting.

Condition small for gestational age (sga)
Treatment somatropin
Sponsor Pfizer
Start date September 2013
End date January 2017
Trial size 500 participants
Trial identifier NCT01897766, A6281314

Summary

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients administered Somatropin.
somatropin
0.23 mg to 0.48 mg/kg/week

Primary Outcomes

Measure
Change in growth rate SD score for calendar age
time frame: 6 years maximum
Change in height SD score for calendar age
time frame: 6 years maximum

Secondary Outcomes

Measure
Final height
time frame: 6 years maximum

Eligibility Criteria

Male or female participants up to 20 years old.

Inclusion Criteria: - A patient who was administered Somatropin (Genotropin). Exclusion Criteria:

Additional Information

Official title Special Investigation For Genotropin(Sga Long Follow-up)
Description All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pfizer.