Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
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).
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.
Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration
A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (
A patient who is SGA and older than 3 years.
A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).
Small for Gestational Age (SGA)
0.23 mg to 0.48 mg/kg/week
Other Name: Genotropin
Patients administered Somatropin.
Intervention: Drug: Somatropin
* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Actual Enrollment (submitted: January 29, 2020)
Original Estimated Enrollment (submitted: July 9, 2013)
Actual Study Completion Date
June 7, 2017
Actual Primary Completion Date
February 28, 2017 (Final data collection date for primary outcome measure)
A patient who was administered Somatropin (Genotropin).
Sexes Eligible for Study:
2 Years to 20 Years (Child, Adult)
Accepts Healthy Volunteers
Contact information is only displayed when the study is recruiting subjects
Listed Location Countries
Removed Location Countries
Other Study ID Numbers
Has Data Monitoring Committee
U.S. FDA-regulated Product
IPD Sharing Statement
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Pfizer CT.gov Call Center
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Contact a representative by phone, email, or visiting the study website. Please see the references below: