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

Fetal Growth Retardation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174252
• Other study ID #: A6281234
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: June 10, 2010
• Start date: February 2005
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Drug:
• Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	ANGERS Cedex 03
France	Pfizer Investigational Site	Besançon
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Bron Cedex
France	Pfizer Investigational Site	Caen Cedex 5
France	Pfizer Investigational Site	Dunkerque Cedex 1
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Limoges Cedex
France	Pfizer Investigational Site	Lorient
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	PARIS Cedex 19
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Rouen
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Tarbes
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Tours
France	Pfizer Investigational Site	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 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.	9 and 12 months	Yes
Secondary	Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 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".	Baseline, 12 months	No
Secondary	Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 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 "24 months" minus height in SD at "Baseline".	Baseline, 24 months	No
Secondary	Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 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 or 24 months" minus height in SD at "Baseline".	Baseline, 12 and 24 months	No
Secondary	Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 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".	Baseline, 12 months	No
Secondary	Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 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 "24 months" minus height in SD at "Baseline".	Baseline, 24 months	No
Secondary	Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 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 or 24 months" minus height in SD at "Baseline".	Baseline, 12 and 24 months	No
Secondary	Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 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	12 and 24 months	No
Secondary	Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 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	12 and 24 months	No
Secondary	Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 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	Baseline, 12 months	No
Secondary	Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 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 BA at 24 months	Baseline, 24 months	No
Secondary	Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 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 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	12 and 24 months	No
Secondary	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	Change in Height SD (CA) was calculated as: Height SD (CA) at 12 months minus Height SD (CA) at Baseline	Baseline, 12 months	No
Secondary	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	Height SD (CA) at 24 months.	Baseline, 24 months	No
Secondary	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	Change in Height SD (BA) was calculated as: Height SD (BA) at 12 months minus Height SD (BA) at Baseline	Baseline, 12 months	No
Secondary	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	Height SD (BA) at 24 months	Baseline, 24 months	No
Secondary	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	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	6, 9, 12, 15, 18, 21, and 24 months	Yes
Secondary	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	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	6, 9, 12, 15, 18, 21, and 24 months	Yes
Secondary	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	Yes
Secondary	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	Yes

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