Phase 3
N=43
Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
Bottom Line
View on ClinicalTrials.gov: NCT00627523 ↗Enrolled (actual)
43
Serious AEs
18.6%
Results posted
Sep 2014
Primary outcome: Primary: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. — 1.63; 0.43 SDS — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Genotropin (PN-180,307) Somatropin (Drug); Control-no treatment (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. |
1.63; 0.43 | <0.001 sig |
| SECONDARY Change From Baseline in Growth Velocity SDS at Month 24. |
0.74; -0.03 | 0.348 |
| SECONDARY Change From Baseline in Height SDS at Month 12. |
1.03; 0.14 | <0.001 sig |
| SECONDARY Change From Baseline in Growth Velocity SDS at Month 12. |
1.65; -1.59 | <0.001 sig |
| SECONDARY Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. |
10.97; 8.55 | 0.738 |
| SECONDARY Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. |
4.04; 8.55 | 0.301 |
| SECONDARY Head Circumference SDS at Months 3, 6, 12, 18 and 24. |
-0.93; -1.37; -1.20; -1.72; -0.87; -1.84 | — |
| SECONDARY Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. |
0.27; 0.36; -0.00; 0.07; 0.26; 0.02 | — |
| SECONDARY Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. |
0.57; 0.53; 1.08; 1.01; 2.34; 1.66 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. |
-0.28; -0.05; -0.57; 0.08; -0.62; -0.29 | — |
Summary
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
Eligibility Criteria
Inclusion Criteria
Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.
Born SGA (birth length and/or weight 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.
Data sourced from ClinicalTrials.gov (NCT00627523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.