Phase 3
N=208
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Bottom Line
View on ClinicalTrials.gov: NCT01073605 ↗Enrolled (actual)
208
Serious AEs
3.4%
Results posted
Aug 2010
Primary outcome: Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Genotonorm (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm |
3.07; 3.97; 2.84 | 0.02922 sig |
| SECONDARY Annual Growth Rate Standard Deviation Score (SDS) |
-2.72; -2.58; -2.75; 2.14; 3.97; 1.71 | — |
| SECONDARY Change From Baseline in Annual Growth Rate SDS |
4.81; 6.56; 4.37; 3.51; 4.53; 3.37 | 0.00125 sig |
| SECONDARY Height (cm) |
105.22; 107.06; 106.44; 113.38; 116.31; 113.71 | — |
| SECONDARY Change From Baseline in Height (cm) |
8.21; 9.21; 7.33; 14.77; 17.01; 13.92 | — |
| SECONDARY Height (SDS) |
-3.16; -3.07; -3.21; -2.49; -2.17; -2.68 | — |
| SECONDARY Change From Baseline in Height (SDS) |
0.67; 0.88; 0.53; 0.94; 1.40; 0.84 | 0.0001 sig |
| SECONDARY Body Mass Index (BMI) |
14.74; 15.14; 14.59; 14.82; 15.44; 14.87 | — |
| SECONDARY Weight |
16.77; 17.70; 16.79; 19.71; 21.29; 19.56 | — |
| SECONDARY Change From Baseline in Bone Age |
1.17; 1.27; 1.25; 2.40; 2.50; 2.58 | — |
| SECONDARY Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio |
0.96; 1.07; 1.06; 1.06; 1.14; 1.18 | — |
| SECONDARY Chronological Age at Onset of Puberty |
11.88; 11.12; 11.58 | 0.0681 |
| SECONDARY Number of Subjects Reaching Puberty |
25; 31; 39; 43; 39; 29 | — |
Summary
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Eligibility Criteria
Inclusion Criteria
- Chronological age (CA) between 3 and 10 for girls
- Chronological age between 3 and 12 for boys
- Height for CA below - 2 SD
- Birth length for CA below -2SD
Exclusion Criteria
- Endocrine disease except well-substituted hypothyroidism
- Sever chronic disease
- Skeletal dysplasia
- Known chromosomal aberration
- Ongoing treatment with steroids
- Known intrauterine infection
Data sourced from ClinicalTrials.gov (NCT01073605). 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.