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: January 21, 2014
Last verified: January 2014

February 22, 2008
January 21, 2014
February 2008
December 2013   (final data collection date for primary outcome measure)
The primary endpoint is the change from baseline in height SDS (Standard Deviation Score) after 24 months of treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The primaty endpoint is the change from baseline in height SDS (Standard Deviation Score) and height velocity SDS, after 24 months of treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627523 on ClinicalTrials.gov Archive Site
  • Change from baseline in height velocity SDS after 24 months of treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in height SDS and height velocity SDS after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in mental and psychomotor development using the MDI and PDI (normalized using US ranges) of the Bayley Scale after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Head circumference (SDS) [cm] at all time points of the study [ Time Frame: all visits ] [ Designated as safety issue: No ]
  • Change from baseline in body weight and Body Mass Index (BMI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in height SDS and height velocity SDS, after 12 months of treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in mental and psychomotor development using the MDI and PDI (normalized using US ranges) of the Bayley Scale after 12 months of treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Head circumference (SDS) [cm] at all time points of the study. [ Time Frame: all visits ] [ Designated as safety issue: No ]
  • Change from baseline in body weight and Body Mass Index (BMI). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Genotropin Treatment In Very Young Children Born Small For Gestational Age
A Two-Year Multi-Centre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment

To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infant, Small for Gestational Age
  • Drug: Genotropin (PN-180,307) Somatropin
    Injectable Genotropin
    Other Name: Genotropin (PN-180,307) Somatropin
  • Drug: Control-no treatment
    Control-no treatment
  • Experimental: Active
    The active treatment arm
    Intervention: Drug: Genotropin (PN-180,307) Somatropin
  • Experimental: Control
    Control
    Intervention: Drug: Control-no treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.

Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).

Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.

Exclusion Criteria:

Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.

Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).

Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.

Defined neurological defects and/or severe neurodevelopmental delay.

Both
19 Months to 55 Months
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland
 
NCT00627523
A6281287
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

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