Genotropin Treatment In Very Young Children Born Small For Gestational Age (EGN)
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00627523
First received: February 22, 2008
Last updated: April 29, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 42 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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
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 | |
| Gorg, 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: | April 29, 2013 |
| Health Authority: | Brussels: Ethical Review |
ClinicalTrials.gov processed this record on May 16, 2013