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Trial record 1 of 1 for:    NCT01073605
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Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

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ClinicalTrials.gov Identifier: NCT01073605
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : August 31, 2010
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE February 23, 2010
Results First Submitted Date  ICMJE May 6, 2010
Results First Posted Date  ICMJE August 31, 2010
Last Update Posted Date November 18, 2010
Study Start Date  ICMJE July 1993
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
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}
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
Change from baseline in annual growth rate (cm/year) measured after 24 months treatment with growth hormone (GH) [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
  • Annual Growth Rate Standard Deviation Score (SDS) [ Time Frame: Baseline, 1 to 6 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    BMI was calculated by weight divided by height squared.
  • Weight [ Time Frame: Baseline, 1 to 6 years ]
  • Change From Baseline in Bone Age [ Time Frame: Baseline, 1 to 3 years ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
  • Annual growth rate and change in annual growth rate in standard deviation score (SDS) [ Time Frame: every year ]
  • Height measured by use of a wallmonted device and change in height (in cm and SDS) [ Time Frame: every 3 months up to 2 years and amended up to final height ]
  • Weight measured by use of a balanced scale and body mass index (weight divided by height squared) [ Time Frame: every 3 months up to 2 years and amended up to final height ]
  • Bone age measured on an X-ray of the wrist [ Time Frame: every 12 months ]
  • Adverse events obtained by spontaneous reporting by the patient or by active questionning of the investigator [ Time Frame: every 3 months and after GH withdrawal ]
  • Fasting glucose, HbA1c, thyroxine T4 [ Time Frame: Every 12 months ]
  • Pubertal stage measured by testis vomune in boys and breast development in girls [ Time Frame: Every 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Official Title  ICMJE A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
Brief Summary To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Disorders
  • Intrauterine Growth Retardation
Intervention  ICMJE
  • Drug: Genotonorm
    0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
  • Drug: Genotonorm
    1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
  • 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)
Study Arms  ICMJE
  • Active Comparator: Genotonorm A
    Continuous 0.7 IU/kg/week or 0.03 mg/kg/day
    Intervention: Drug: Genotonorm
  • Active Comparator: Genotonorm B
    Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day
    Intervention: Drug: Genotonorm
  • Active Comparator: Genotonorm C
    Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
    Intervention: Drug: Genotonorm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2010)
208
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01073605
Other Study ID Numbers  ICMJE 93-8122-001
A6281186, CTN 93-8122-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP