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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174252
First received: September 9, 2005
Last updated: June 10, 2010
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Fetal Growth Retardation
Drug: Genotonorm (Somatropin)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: February 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genotonorm (Somatropin) Drug: Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174252

Locations
France
Pfizer Investigational Site
Amiens, France, 80030
Pfizer Investigational Site
ANGERS Cedex 03, France, 49000
Pfizer Investigational Site
Besançon, France, 25030
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Bron Cedex, France, 69677
Pfizer Investigational Site
Caen Cedex 5, France, 14033
Pfizer Investigational Site
Dunkerque Cedex 1, France, 59385
Pfizer Investigational Site
Lille, France, 59019
Pfizer Investigational Site
Limoges Cedex, France, 87042
Pfizer Investigational Site
Lorient, France
Pfizer Investigational Site
Nice, France, 06202
Pfizer Investigational Site
Paris, France, 75743
Pfizer Investigational Site
Paris, France, 75571
Pfizer Investigational Site
PARIS Cedex 19, France, 75935
Pfizer Investigational Site
Rennes, France, 35203
Pfizer Investigational Site
Rouen, France, 76000
Pfizer Investigational Site
Strasbourg, France, 67098
Pfizer Investigational Site
Tarbes, France, 65000
Pfizer Investigational Site
Toulouse, France, 31026
Pfizer Investigational Site
Toulouse, France, 31000
Pfizer Investigational Site
Tours, France, 37044
Pfizer Investigational Site
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00174252     History of Changes
Other Study ID Numbers: A6281234
Study First Received: September 9, 2005
Results First Received: April 2, 2010
Last Updated: June 10, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014