Phase 3 N=57 Treatment

Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Fetal Growth Retardation

Bottom Line

View on ClinicalTrials.gov: NCT00174252 ↗

Enrolled (actual)

Serious AEs

10.5%

Results posted

Jun 2010

Primary outcome: Primary: Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months — 86.0; 14.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Genotonorm (Somatropin) (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months	86.0; 14.0	—
SECONDARY Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	0.81	—
SECONDARY Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	1.24	—
SECONDARY Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	1.13; 1.53	—
SECONDARY Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	0.44	—
SECONDARY Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	0.12	—
SECONDARY Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	0.64; 0.64	—
SECONDARY Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	3.77; 1.74	—
SECONDARY Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	5.24; 2.15	—
SECONDARY Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	2.38	—
SECONDARY Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	1.26	—
SECONDARY Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	4.02; 1.71	—
SECONDARY Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	-1.94; -1.59	0.002 sig
SECONDARY ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	-1.53; -1.18	0.023 sig
SECONDARY ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	0.56; 0.76	0.708
SECONDARY ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	0.05; 0.64	0.325
SECONDARY Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	0.65; 0.93; 1.04; 0.88; 0.88; 0.82	—
SECONDARY Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	2.32; 2.35; 2.50; 1.40; 2.12; 1.82	—
SECONDARY IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	0.17; 0.19	—
SECONDARY IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	0.23; 0.21	—

Summary

To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Eligibility Criteria

Inclusion Criteria

Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
Measured Height or = 4 ml in boys and breast stage > or = B2 (Tanner)
Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00174252). 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.