Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)

Pfizer19 sites in 1 country62 target enrollmentOctober 2002

Overview

Phase: Phase 4
Intervention: Genotropin (somatropin)
Conditions: Short Stature Born Small for Gestational Age (SGA)
Sponsor: Pfizer
Enrollment: 62
Locations: 19
Primary Endpoint: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 10 years ago

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

August 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

•Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
•Children who have received radiotherapy or chemotherapy.
•Children who have serious cardiac disease, renal disease, or hepatic disease.
•Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
•Children who have serious chronic disease.
•Children who have malignant tumor.
•Children who are allergic to m-cresol.

Intervention: Genotropin (somatropin)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame: Month 12 (at the end of previous study) to 156

Height SDS for Chronological Age(Month 12 (at the end of previous study) to 156)
Height Velocity SDS for Bone Age(Month 12 (at the end of previous study) to 156)
Height Velocity Standard Deviation Score (SDS) for Chronological Age(Month 12 (at the end of previous study) to 156)
Height Velocity(Month 12 (at the end of previous study) to 156)
Height SDS for Bone Age(Month 12 (at the end of previous study) to 156)