Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

Growth Disorders Clinical Trial

Official title:

A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073605
• Other study ID #: 93-8122-001
• Secondary ID: A6281186, CTN 93
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2010
• Last updated: November 8, 2010
• Start date: July 1993
• Est. completion date: May 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Growth Disorders
• Intrauterine Growth Retardation

Intervention

Drug:
• Genotonorm
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
• Genotonorm
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
• Genotonorm
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	Angers cedex
France	Pfizer Investigational Site	Besancon Cedex
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Boulogne
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Bron Cedex
France	Pfizer Investigational Site	Clermont Ferrand
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Grenoble
France	Pfizer Investigational Site	Hyères
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Marseille cedex 5
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Nantes Cedex 1
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Reims
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Rouen
France	Pfizer Investigational Site	Saint Priest en Jarez
France	Pfizer Investigational Site	Strasbourg Cedex 2
France	Pfizer Investigational Site	Tarbes
France	Pfizer Investigational Site	Toulouse Cedex
France	Pfizer Investigational Site	Tours
France	Pfizer Investigational Site	Vandoeuvre Les Nancy Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm	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}	Baseline, 2 years	No
Secondary	Annual Growth Rate Standard Deviation Score (SDS)	Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.	Baseline, 1 to 6 years	No
Secondary	Change From Baseline in Annual Growth Rate SDS	Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.	Baseline, 1 to 3 years	No
Secondary	Height (cm)	Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.	Baseline, 1 to 6 years, final height	No
Secondary	Change From Baseline in Height (cm)	Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.	Baseline, 1 to 6 years, final height	No
Secondary	Height (SDS)	Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.	Baseline, 1 to 6 years, final height	No
Secondary	Change From Baseline in Height (SDS)	Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.	Baseline, 1 to 6 years, final height	No
Secondary	Body Mass Index (BMI)	BMI was calculated by weight divided by height squared.	Baseline, 1 to 6 years	No
Secondary	Weight		Baseline, 1 to 6 years	No
Secondary	Change From Baseline in Bone Age	Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year	Baseline, 1 to 3 years	Yes
Secondary	Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio	Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.	1 to 3 years	Yes
Secondary	Chronological Age at Onset of Puberty	Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.	Onset of puberty	Yes
Secondary	Number of Subjects Reaching Puberty	The defined criteria for reaching puberty were: boy=if right or left testes volume =4 ml; girl=if breast development =2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.	Baseline, 1 to 6 years	Yes

External Links

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