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

February 22, 2008
September 10, 2014
February 2008
December 2013   (final data collection date for primary outcome measure)
Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values.
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 Growth Velocity SDS at Month 24. [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
    The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values.
  • Change From Baseline in Height SDS at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values.
  • Change From Baseline in Growth Velocity SDS at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values.
  • Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    The Bayley Scale of Infant Development (BSID-II) measured the mental and motor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI. The MDI score of 69 and below indicated significantly delayed performance, 70 to 84 indicated mildly delayed performance, 85 to 114 indicated normal limit, and 115 and above indicated accelerated performance.
  • Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BSID-II measured the mental and motor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI. The PDI score of 69 and below indicated significantly delayed performance, 70 to 84 indicated mildly delayed performance, 85 to 114 indicated normal limit, and 115 and above indicated accelerated performance.
  • Head Circumference SDS at Months 3, 6, 12, 18 and 24. [ Time Frame: Months 3, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender.
  • 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. ] [ Designated as safety issue: No ]
    Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender.
  • Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. [ Time Frame: Baseline, Months 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.
  • 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 ] [ Designated as safety issue: No ]
    Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.
  • 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
Germany,   Belgium,   Czech Republic,   France,   Switzerland,   Italy,   Netherlands,   Spain,   Sweden
 
NCT00627523
A6281287
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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