Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Phase 3

Completed

• Conditions: Fetal Growth Retardation
• Interventions: Drug: Genotonorm (Somatropin)

• Registration Number: NCT00174252
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-06
• Results First Submitted: 2010-04-02
• Results First Submitted QC: 2010-05-04
• Results First Posted: 2010-06-04
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genotonorm (Somatropin)	Genotonorm (Somatropin)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months	9 and 12 months	Percentage of children with serum IGF-1 \> 2 SD (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. 9 months and 12 months are combined.

Secondary Outcome Measures

Name	Time	Method
Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 12 months	The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".
Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 24 months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".
Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	Baseline, 12 and 24 months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".
Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 12 months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".
Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 24 months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".
Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	Baseline, 12 and 24 months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".
Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	12 and 24 months	Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months; Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months
Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	12 and 24 months	Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months; Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months
Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 12 months	Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months
Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Baseline, 24 months	Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months
Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	12 and 24 months	Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months; Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months
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	Baseline, 12 months	Change in Height SD (CA) was calculated as: Height SD (CA) at 12 months minus Height SD (CA) at Baseline
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	Baseline, 24 months	Height SD (CA) at 24 months.
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	Baseline, 12 months	Change in Height SD (BA) was calculated as: Height SD (BA) at 12 months minus Height SD (BA) at Baseline
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	Baseline, 24 months	Height SD (BA) at 24 months
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	6, 9, 12, 15, 18, 21, and 24 months	IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD
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	6, 9, 12, 15, 18, 21, and 24 months	IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 - reference mean) / reference SD
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	12 and 24 months
IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	12 and 24 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Vandoeuvre Les Nancy, France