EVOLUTION OF GROWTH RATE IN CHILDREN WITH GROWTH RETARDATION RELATED TO LONG-TERM GLUCOCORTICOSTEROID THERAPY AND TREATED BY GENOTONORM®

Pfizer, Inc.0 sites98 target enrollmentMay 14, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 14, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Evidence of a personally signed and dated informed consent document indicating that
•the subject (or a legal representative) has been informed of all pertinent aspects of the study.
•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
•Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
•Have undergone hysterectomy or bilateral oophorectomy;
•Have medically confirmed ovarian failure or
•Are medically confirmed to be post menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation LH and FSH may be indicated if menopause is in doubt.
•Subjects who are clinically pre pubertal
•A request for GH treatment may be issued if all the following criteria are fulfilled

•1\. Glucose intolerance on an Oral Glucose Tolerance Test dated less than 3 months or
•diabetes mellitus.
•2\. Syndrome known to be associated with an increased risk of cancer eg, family history
•of adenomatous polyposis.
•3\. Pathological condition or disease for which GH treatment is already approved in France.
•4\. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
•5\. Unable and/or unlikely to comprehend and/or follow GH treatment and/or the protocol.
•6\. A previous history of intolerance or hypersensitivity to the study drug, or to drugs with
•similar chemical structures.
•7\. Patients who are known or are suspected allergic to the preservative metacresol