Evolution of Growth Rate in Children Suffering From aDisease Associated With Growth Retardation and Treated byGenotonorm. A Pilot Study

Pfizer Inc0 sites46 target enrollmentApril 1, 2015

Overview

No summary available.

Registry

who.int

Start Date

April 1, 2015

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. For GH treatment issue bone age should be less than (\<) 13 years for a boy and \< 11 years for a girl.2\. Naïve child: with measured height should be \< 2\.5 SD for chronological age (CA).
•Child currently treated by GH should have annual growth rate greater than equal to (\>\=) \+1 SD and measured height \<\-2\.5 SD for CA at the time GH was started.
•3\. Documented disease or pathological conditions known to be associated with growth
•retardation and/or an adult height \< \-2 SD.
•4\. Children with the same pathological condition or disease.
•5\. Genotonorm treatment can be initiated by a physician according to the French SCP. that is to say a physician working in a hospital pediatric department or in a hospital endocrinology and metabolic disease department and, who is a pediatrician and/or a pediatric endocrinologist
•6\. The child benefits of the French social security cover.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 46
•F.1\.2 Adults (18\-64 years) no

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