This trial has been completed.

Condition small for gestational age (sga)
Treatment somatropin
Sponsor Pfizer
Start date September 2013
End date February 2017
Trial size 488 participants
Trial identifier NCT01897766, A6281314


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
Patients administered Somatropin.
0.23 mg to 0.48 mg/kg/week

Primary Outcomes

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

Final height
time frame: 6 years maximum

Eligibility Criteria

All 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 April 2017.
Information provided to ClinicalTrials.gov by Pfizer.