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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01073605
First received: February 22, 2010
Last updated: November 8, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Growth Disorders
Intrauterine Growth Retardation
Drug: Genotonorm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Annual Growth Rate Standard Deviation Score (SDS) [ Time Frame: Baseline, 1 to 6 years ] [ Designated as safety issue: No ]
    Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.

  • Change From Baseline in Annual Growth Rate SDS [ Time Frame: Baseline, 1 to 3 years ] [ Designated as safety issue: No ]
    Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.

  • Height (cm) [ Time Frame: Baseline, 1 to 6 years, final height ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Height (cm) [ Time Frame: Baseline, 1 to 6 years, final height ] [ Designated as safety issue: No ]
    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.

  • Height (SDS) [ Time Frame: Baseline, 1 to 6 years, final height ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Height (SDS) [ Time Frame: Baseline, 1 to 6 years, final height ] [ Designated as safety issue: No ]
    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.

  • Body Mass Index (BMI) [ Time Frame: Baseline, 1 to 6 years ] [ Designated as safety issue: No ]
    BMI was calculated by weight divided by height squared.

  • Weight [ Time Frame: Baseline, 1 to 6 years ] [ Designated as safety issue: No ]
  • Change From Baseline in Bone Age [ Time Frame: Baseline, 1 to 3 years ] [ Designated as safety issue: Yes ]
    Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year

  • Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio [ Time Frame: 1 to 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Chronological Age at Onset of Puberty [ Time Frame: Onset of puberty ] [ Designated as safety issue: Yes ]
    Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.

  • Number of Subjects Reaching Puberty [ Time Frame: Baseline, 1 to 6 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 208
Study Start Date: July 1993
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Genotonorm A
Continuous 0.7 IU/kg/week or 0.03 mg/kg/day
Drug: Genotonorm
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
Active Comparator: Genotonorm B
Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day
Drug: Genotonorm
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
Active Comparator: Genotonorm C
Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
Drug: 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)

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073605

Locations
France
Pfizer Investigational Site
Amiens, France, 80030
Pfizer Investigational Site
Angers cedex, France, 49933
Pfizer Investigational Site
Besancon Cedex, France, 25030
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Bordeaux Cedex, France, 33076
Pfizer Investigational Site
Boulogne, France, 92100
Pfizer Investigational Site
Brest, France, 29200
Pfizer Investigational Site
Bron Cedex, France, 69677
Pfizer Investigational Site
Clermont Ferrand, France, 63000
Pfizer Investigational Site
Dijon, France, 21034
Pfizer Investigational Site
Grenoble, France, 38043
Pfizer Investigational Site
Hyères, France, 83407
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Lille, France, 59000
Pfizer Investigational Site
Marseille cedex 5, France, 13385
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Nantes Cedex 1, France, 44093
Pfizer Investigational Site
Nice, France, 06202
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Paris, France, 75674
Pfizer Investigational Site
Paris, France, 75571
Pfizer Investigational Site
Reims, France, 51092
Pfizer Investigational Site
Rennes, France, 35033
Pfizer Investigational Site
Rouen, France, 76000
Pfizer Investigational Site
Saint Priest en Jarez, France, 42277
Pfizer Investigational Site
Strasbourg Cedex 2, France, 67098
Pfizer Investigational Site
Tarbes, France
Pfizer Investigational Site
Toulouse Cedex, France, 31026
Pfizer Investigational Site
Tours, France, 37044
Pfizer Investigational Site
Vandoeuvre Les Nancy Cedex, France, 54511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01073605     History of Changes
Other Study ID Numbers: 93-8122-001, A6281186, CTN 93-8122-001
Study First Received: February 22, 2010
Results First Received: May 6, 2010
Last Updated: November 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pfizer:
Short height
intra-uterine growth retardation
Genotonorm
continuous treatment
intermittent treatment

Additional relevant MeSH terms:
Fetal Growth Retardation
Growth Disorders
Fetal Diseases
Pregnancy Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014