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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
History of Changes
Results First Received: April 2, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fetal Growth Retardation
Intervention: Drug: Genotonorm (Somatropin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Genotonorm Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.

Participant Flow:   Overall Study
    Genotonorm  
STARTED     57  
COMPLETED     55  
NOT COMPLETED     2  
Protocol Violation                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Genotonorm Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.

Baseline Measures
    Genotonorm  
Number of Participants  
[units: participants]
 		  57  
Age, Customized  
[units: participants]
 		 
<4 years     1  
Between 4 and 8 years     49  
Between 8 and 12 years     7  
>=12 years     0  
Gender  
[units: participants]
 		 
Female     34  
Male     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  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   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  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   [ Time Frame: Baseline, 12 and 24 months ]
  Show Outcome Measure 4

5.  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   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 5

6.  Secondary:   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 ]
  Show Outcome Measure 6

7.  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   [ Time Frame: Baseline, 12 and 24 months ]
  Show Outcome Measure 7

8.  Secondary:   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 ]
  Show Outcome Measure 8

9.  Secondary:   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 ]
  Show Outcome Measure 9

10.  Secondary:   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 ]
  Show Outcome Measure 10

11.  Secondary:   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 ]
  Show Outcome Measure 11

12.  Secondary:   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 ]
  Hide Outcome Measure 12

Measure Type Secondary
Measure Title Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months
Measure 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
Time Frame 12 and 24 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.

Reporting Groups
  Description
Genotonorm Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.

Measured Values
    Genotonorm  
Number of Participants Analyzed  
[units: participants]
 		  7  
Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months  
[units: SD for BA]
Mean ± Standard Deviation 		 
12 Months     4.02  ± 2.37  
24 Months (n=6)     1.71  ± 2.26  

No statistical analysis provided for Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months



13.  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   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 13

14.  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   [ Time Frame: Baseline, 24 months ]
  Show Outcome Measure 14

15.  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   [ Time Frame: Baseline, 12 months ]
  Show Outcome Measure 15

16.  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   [ Time Frame: Baseline, 24 months ]
  Show Outcome Measure 16

17.  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   [ Time Frame: 6, 9, 12, 15, 18, 21, and 24 months ]
  Show Outcome Measure 17

18.  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   [ Time Frame: 6, 9, 12, 15, 18, 21, and 24 months ]
  Show Outcome Measure 18

19.  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   [ Time Frame: 12 and 24 months ]
  Show Outcome Measure 19

20.  Secondary:   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 ]
  Show Outcome Measure 20

21.  Other Pre-specified:   Change in Height From Baseline   [ Time Frame: Baseline, 12 and 24 months ]
  Show Outcome Measure 21

22.  Other Pre-specified:   Growth Rate at 12 and 24 Months   [ Time Frame: 12 and 24 months ]
  Show Outcome Measure 22

23.  Other Pre-specified:   Summary of Body Mass Index (BMI) at 12 and 24 Months   [ Time Frame: 12 and 24 months ]
  Show Outcome Measure 23

24.  Other Pre-specified:   Change in BA From Baseline at 12 and 24 Months   [ Time Frame: Baseline, 12 and 24 months ]
  Show Outcome Measure 24

25.  Other Pre-specified:   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 ]
  Show Outcome Measure 25

26.  Other Pre-specified:   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 ]
  Show Outcome Measure 26


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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)