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

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ClinicalTrials.gov Identifier: NCT00174252
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : June 4, 2010
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE April 2, 2010
Results First Posted Date  ICMJE June 4, 2010
Last Update Posted Date June 15, 2010
Study Start Date  ICMJE February 2005
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2010)
Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Auxologic parameters. 1st & 2nd year growth rate. chronological and bone age
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2010)
  • Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 and 24 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 4, 2010)
  • Change in Height From Baseline [ Time Frame: Baseline, 12 and 24 months ]
    The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.
  • Growth Rate at 12 and 24 Months [ Time Frame: 12 and 24 months ]
    Growth Rate was calculated at 12 months as: (Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25} Growth Rate was calculated at 24 months as: (Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}
  • Summary of Body Mass Index (BMI) at 12 and 24 Months [ Time Frame: 12 and 24 months ]
    BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared
  • Change in BA From Baseline at 12 and 24 Months [ Time Frame: Baseline, 12 and 24 months ]
    Change in BA was calculated as: (12 or 24 months minus Screening)
  • BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months [ Time Frame: 12 and 24 months ]
    The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.
  • BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months [ Time Frame: 12 and 24 months ]
    The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Official Title  ICMJE Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fetal Growth Retardation
Intervention  ICMJE Drug: Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
Study Arms  ICMJE Experimental: Genotonorm (Somatropin)
Intervention: Drug: Genotonorm (Somatropin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
57
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
100
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174252
Other Study ID Numbers  ICMJE A6281234
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP