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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00174252 (opens ClinicalTrials.gov in a new tab)Other idA6281234
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Overview

Status
Completed
Phase
Phase 3
Enrollment
57 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Feb 2005
Primary completion
Apr 2009
Completion
Apr 2009
First posted
15 Sept 2005 (estimated)
Last update posted
15 Jun 2010 (estimated)
Conditions
Fetal Growth Retardation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007200820092010
  1. Ph 3

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

    NCT00174252

    Feb 2005 to Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Genotonorm (Somatropin)Drug

Arms1

  • Experimental

    Genotonorm (Somatropin)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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 outcomes(19)

  1. 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

    Registry description

    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".

  2. 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

    Registry description

    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".

  3. 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

    Registry description

    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".

  4. 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

    Registry description

    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".

  5. 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

    Registry description

    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".

  6. 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

    Registry description

    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".

  7. 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

    Registry description

    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

  8. 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

    Registry description

    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

  9. 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

    Registry description

    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

  10. 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

    Registry description

    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

  11. 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

    Registry description

    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. 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

    Registry description

    Change in Height SD (CA) was calculated as: Height SD (CA) at 12 months minus Height SD (CA) at Baseline

  13. 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

    Registry description

    Height SD (CA) at 24 months.

  14. 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

    Registry description

    Change in Height SD (BA) was calculated as: Height SD (BA) at 12 months minus Height SD (BA) at Baseline

  15. 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

    Registry description

    Height SD (BA) at 24 months

  16. 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

    Registry description

    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

  17. 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

    Registry description

    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

  18. 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

  19. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 9 and 12 months

Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months

GroupValue (percentage of participants)
Genotonorm86.0
Secondary and other outcome results(7)
Other pre specified outcomeMean· Baseline, 12 and 24 months

Change in Height From Baseline

GroupValue (centimeters (cm))Spread
Genotonorm9.01.3
Secondary outcomeMean· Baseline, 12 months

Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

GroupValue (SD for CA)Spread
Genotonorm0.810.26
Secondary outcomeMean· Baseline, 24 months

Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

GroupValue (SD for CA)Spread
Genotonorm1.240.48
Secondary outcomeMean· Baseline, 12 and 24 months

Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months

GroupValue (SD for BA)Spread
Genotonorm1.130.35
Secondary outcomeMean· Baseline, 12 months

Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

GroupValue (SD for BA)Spread
Genotonorm0.441.34
Secondary outcomeMean· Baseline, 24 months

Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

GroupValue (Height in SD)Spread
Genotonorm0.121.86
Secondary outcomeMean· Baseline, 12 and 24 months

Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months

GroupValue (SD for BA)Spread
Genotonorm0.641.19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GenotonormInitiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.–6 / 5730 / 57

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years up to 9 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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