Genotropin Treatment In Very Young Children Born Small For Gestational Age (EGN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00627523
First received: February 22, 2008
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: September 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infant, Small for Gestational Age
Interventions: Drug: Genotropin (PN-180,307) Somatropin
Drug: Control-no treatment

  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
This randomized controlled trial enrolled small for gestational age (SGA) children at 16 centers in 8 countries. In total, 52 participants were screened for the study, of these, 9 participants were considered screen failures. The remaining 43 participants were randomized to receive either study drug (Genotropin®) or were not treated (Control).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants aged between 19 to 29 months at Screening visit, born SGA (birth length and/or weight <-2 standard deviations (SD) for gestational age, using country-specific standards), height below -2.5 SD at Screening (19-29 months of age), and had at least one measurement of length between 12 and 18 months of age were enrolled in this study.

Reporting Groups
  Description
Genotropin® Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
Control This group was the untreated control group and was not administered placebo.

Participant Flow:   Overall Study
    Genotropin®     Control  
STARTED     21 [1]   22  
COMPLETED     19     20  
NOT COMPLETED     2     2  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 0                 2  
Not specified                 1                 0  
[1] 22 assigned to Genotropin and 21 in Control; 1 did not take Genotropin, so considered as Control.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Genotropin® Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
Control This group was the untreated control group and was not administered placebo.
Total Total of all reporting groups

Baseline Measures
    Genotropin®     Control     Total  
Number of Participants  
[units: participants]
  21     22     43  
Age  
[units: Months]
Mean ± Standard Deviation
  24.91  ± 3.262     24.44  ± 3.324     24.67  ± 3.263  
Gender  
[units: Participants]
     
Female     13     11     24  
Male     8     11     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.   [ Time Frame: Baseline and Month 24 ]

2.  Secondary:   Change From Baseline in Growth Velocity SDS at Month 24.   [ Time Frame: Baseline and Month 24 ]

3.  Secondary:   Change From Baseline in Height SDS at Month 12.   [ Time Frame: Baseline and Month 12 ]

4.  Secondary:   Change From Baseline in Growth Velocity SDS at Month 12.   [ Time Frame: Baseline and Month 12 ]

5.  Secondary:   Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.   [ Time Frame: Baseline and Month 12 ]

6.  Secondary:   Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.   [ Time Frame: Baseline and Month 12 ]

7.  Secondary:   Head Circumference SDS at Months 3, 6, 12, 18 and 24.   [ Time Frame: Months 3, 6, 12, 18 and 24 ]

8.  Secondary:   Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.   [ Time Frame: Baseline, Months 3, 6, 12, 18 and 24. ]

9.  Secondary:   Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.   [ Time Frame: Baseline, Months 3, 6, 12, 18, and 24 ]

10.  Secondary:   Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.   [ Time Frame: Baseline, Months 3, 6, 12, 18, and 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00627523     History of Changes
Other Study ID Numbers: A6281287
Study First Received: February 22, 2008
Results First Received: September 10, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration