Growth Retardation in Children With Special Pathological Conditions or Disease

• Conditions: Growth Disorders, Growth Retardation; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2004-002991-40-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
protocol.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show an increase in annual growth rate 3 years after Visit 2. anual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of growth hormone (GH) treatment.;Secondary Objective: To estimate the evolution of height under GH treatment after 1, 2 and 3 years<br>To estimate the growth rate 1 and 2 years after inclusion in the study<br>To confirm the good clinical and biological safety of GH treatment in such children<br>;Primary end point(s): 1) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population<br>2) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population<br>;Timepoint(s) of evaluation of this end point: 1) Baseline, Month 36<br>2) Baseline, Month 36<br>