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
  Purpose

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


Condition Intervention Phase
Infant, Small for Gestational Age
Drug: Genotropin (PN-180,307) Somatropin
Drug: Control-no treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
The active treatment arm
Drug: Genotropin (PN-180,307) Somatropin
Injectable Genotropin
Other Name: Genotropin (PN-180,307) Somatropin
Experimental: Control
Control
Drug: Control-no treatment
Control-no treatment

  Eligibility

Ages Eligible for Study:   19 Months to 55 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627523

Locations
Belgium
Pfizer Investigational Site
Brussel, Belgium, 1090
Pfizer Investigational Site
Edegem, Belgium, 2650
Czech Republic
Pfizer Investigational Site
Olomouc, Czech Republic, 775 20
Pfizer Investigational Site
Ostrava-Poruba, Czech Republic, 708 52
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
France
Pfizer Investigational Site
Toulouse Cedex 9, France, 31059
Germany
Pfizer Investigational Site
Erlangen, Germany, 91054
Italy
Pfizer Investigational Site
Catania, Italy, 95125
Pfizer Investigational Site
Messina, Italy, 98100
Pfizer Investigational Site
Milano, Italy, 20132
Pfizer Investigational Site
Roma, Italy, 00165
Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands, 3015 GJ
Spain
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
Pfizer Investigational Site
Pamplona, Navarra, Spain, 31008
Pfizer Investigational Site
Zaragoza, Spain, 50009
Sweden
Pfizer Investigational Site
Göteborg, Sweden
Switzerland
Pfizer Investigational Site
CH-3010 Bern, Switzerland
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00627523     History of Changes
Other Study ID Numbers: A6281287
Study First Received: February 22, 2008
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 20, 2014