Clinical trial NCT01073605: Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Official title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Disorders
Intrauterine Growth Retardation
Keywords: Short height
intra-uterine growth retardation
Genotonorm
continuous treatment
intermittent treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 208
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation


Eligibility criteria: Inclusion Criteria:

* Chronological age (CA) between 3 and 10 for girls
* Chronological age between 3 and 12 for boys
* Height for CA below - 2 SD
* Birth length for CA below -2SD

Exclusion Criteria:

* Endocrine disease except well-substituted hypothyroidism
* Sever chronic disease
* Skeletal dysplasia
* Known chromosomal aberration
* Ongoing treatment with steroids
* Known intrauterine infection

Primary outcomes:
measure: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: Annual Growth Rate Standard Deviation Score (SDS)
timeFrame: Baseline, 1 to 6 years
measure: Change From Baseline in Annual Growth Rate SDS
timeFrame: Baseline, 1 to 3 years
measure: Height (cm)
timeFrame: Baseline, 1 to 6 years, final height
measure: Change From Baseline in Height (cm)
timeFrame: Baseline, 1 to 6 years, final height
measure: Height (SDS)
timeFrame: Baseline, 1 to 6 years, final height
measure: Change From Baseline in Height (SDS)
timeFrame: Baseline, 1 to 6 years, final height
measure: Body Mass Index (BMI)
timeFrame: Baseline, 1 to 6 years
measure: Weight
timeFrame: Baseline, 1 to 6 years
measure: Change From Baseline in Bone Age
timeFrame: Baseline, 1 to 3 years
measure: Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio
timeFrame: 1 to 3 years
measure: Chronological Age at Onset of Puberty
timeFrame: Onset of puberty
measure: Number of Subjects Reaching Puberty
timeFrame: Baseline, 1 to 6 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Angers cedex
country: France
facility: Pfizer Investigational Site
city: Besancon Cedex
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Boulogne
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Bron Cedex
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Grenoble
country: France
facility: Pfizer Investigational Site
city: Hyères
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Marseille cedex 5
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 1
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Reims
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Saint Priest en Jarez
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex 2
country: France
facility: Pfizer Investigational Site
city: Tarbes
country: France
facility: Pfizer Investigational Site
city: Toulouse Cedex
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: