Clinical trial NCT00174252: Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Official title: Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fetal Growth Retardation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 57
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.


Eligibility criteria: Inclusion Criteria:

* Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
* Measured Height \< -2.5 Standard Deviation

Exclusion Criteria:

* Pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = B2 (Tanner)
* Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Primary outcomes:
measure: Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months
timeFrame: 9 and 12 months
Secondary outcomes:
measure: Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 12 months
measure: Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 24 months
measure: Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 12 and 24 months
measure: Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 12 months
measure: Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 24 months
measure: Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 12 and 24 months
measure: Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: 12 and 24 months
measure: Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: 12 and 24 months
measure: Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 12 months
measure: Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: Baseline, 24 months
measure: Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: 12 and 24 months
measure: Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 12 months
measure: ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 24 months
measure: ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 12 months
measure: ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months
timeFrame: Baseline, 24 months
measure: Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: 6, 9, 12, 15, 18, 21, and 24 months
measure: Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: 6, 9, 12, 15, 18, 21, and 24 months
measure: IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: 12 and 24 months
measure: IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: 12 and 24 months
Other outcomes:
measure: Change in Height From Baseline
timeFrame: Baseline, 12 and 24 months
measure: Growth Rate at 12 and 24 Months
timeFrame: 12 and 24 months
measure: Summary of Body Mass Index (BMI) at 12 and 24 Months
timeFrame: 12 and 24 months
measure: Change in BA From Baseline at 12 and 24 Months
timeFrame: Baseline, 12 and 24 months
measure: BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months
timeFrame: 12 and 24 months
measure: BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
timeFrame: 12 and 24 months
Locations:
city: Amiens
country: France
facility: Pfizer Investigational Site
city: ANGERS Cedex 03
country: France
facility: Pfizer Investigational Site
city: Besançon
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bron Cedex
country: France
facility: Pfizer Investigational Site
city: Caen Cedex 5
country: France
facility: Pfizer Investigational Site
city: Dunkerque Cedex 1
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Limoges Cedex
country: France
facility: Pfizer Investigational Site
city: Lorient
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 19
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Tarbes
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: