A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
Overview
- Phase
- Phase 3
- Intervention
- Genotonorm
- Conditions
- Growth Disorders
- Sponsor
- Pfizer
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Investigators
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
Arms & Interventions
Genotonorm A
Continuous 0.7 IU/kg/week or 0.03 mg/kg/day
Intervention: Genotonorm
Genotonorm B
Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day
Intervention: Genotonorm
Genotonorm C
Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
Intervention: Genotonorm
Outcomes
Primary Outcomes
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
Time Frame: Baseline, 2 years
Annual growth rate was expressed as height velocity (centimeter \[cm\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
Secondary Outcomes
- Annual Growth Rate Standard Deviation Score (SDS)(Baseline, 1 to 6 years)
- Change From Baseline in Annual Growth Rate SDS(Baseline, 1 to 3 years)
- Height (cm)(Baseline, 1 to 6 years, final height)
- Change From Baseline in Height (cm)(Baseline, 1 to 6 years, final height)
- Height (SDS)(Baseline, 1 to 6 years, final height)
- Change From Baseline in Height (SDS)(Baseline, 1 to 6 years, final height)
- Body Mass Index (BMI)(Baseline, 1 to 6 years)
- Weight(Baseline, 1 to 6 years)
- Change From Baseline in Bone Age(Baseline, 1 to 3 years)
- Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio(1 to 3 years)
- Chronological Age at Onset of Puberty(Onset of puberty)
- Number of Subjects Reaching Puberty(Baseline, 1 to 6 years)