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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01073605 (opens ClinicalTrials.gov in a new tab)Other id93-8122-001Other idA6281186, CTN 93-8122-001
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names HGH (somatotropin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
208 participants (actual)
Sponsor
Pfizer · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

France

Start
Jul 1993
Primary completion
May 2009
Completion
May 2009
First posted
23 Feb 2010 (estimated)
Last update posted
18 Nov 2010 (estimated)
Conditions
Growth Disorders · Intrauterine Growth Retardation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1995200020052010
  1. Ph 3

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

    NCT01073605

    Jul 1993 to May 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • GenotonormDrug
  • GenotonormDrug
  • GenotonormDrug

Arms3

  • Active comparator

    Genotonorm A

    Continuous 0.7 IU/kg/week or 0.03 mg/kg/day

  • Active comparator

    Genotonorm B

    Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day

  • Active comparator

    Genotonorm C

    Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm

    Time frame · Baseline, 2 years

    Registry description

    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(12)

  1. Annual Growth Rate Standard Deviation Score (SDS)

    Time frame · Baseline, 1 to 6 years

    Registry description

    Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.

  2. Change From Baseline in Annual Growth Rate SDS

    Time frame · Baseline, 1 to 3 years

    Registry description

    Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.

  3. Height (cm)

    Time frame · Baseline, 1 to 6 years, final height

    Registry description

    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.

  4. Change From Baseline in Height (cm)

    Time frame · Baseline, 1 to 6 years, final height

    Registry description

    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.

  5. Height (SDS)

    Time frame · Baseline, 1 to 6 years, final height

    Registry description

    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.

  6. Change From Baseline in Height (SDS)

    Time frame · Baseline, 1 to 6 years, final height

    Registry description

    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.

  7. Body Mass Index (BMI)

    Time frame · Baseline, 1 to 6 years

    Registry description

    BMI was calculated by weight divided by height squared.

  8. Weight

    Time frame · Baseline, 1 to 6 years

  9. Change From Baseline in Bone Age

    Time frame · Baseline, 1 to 3 years

    Registry description

    Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year

  10. Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio

    Time frame · 1 to 3 years

    Registry description

    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.

  11. Chronological Age at Onset of Puberty

    Time frame · Onset of puberty

    Registry description

    Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.

  12. Number of Subjects Reaching Puberty

    Time frame · Baseline, 1 to 6 years

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, 2 years

Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm

GroupValue (cm/year)Spread
Genotonorm 0.7 (Continuous Treatment)3.072.21
Genotonorm 1.4 (Continuous Treatment)3.971.72
Genotonorm 1.4 (Intermittent Treatment)2.841.71
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, 1 to 6 years

Annual Growth Rate Standard Deviation Score (SDS)

GroupValue (SDS)Spread
Genotonorm 0.7 (Continuous Treatment)-2.721.83
Genotonorm 1.4 (Continuous Treatment)-2.581.39
Genotonorm 1.4 (Intermittent Treatment)-2.751.73
Secondary outcomeMean· Baseline, 1 to 3 years

Change From Baseline in Annual Growth Rate SDS

GroupValue (SDS)Spread
Genotonorm 0.7 (Continuous Treatment)4.812.27
Genotonorm 1.4 (Continuous Treatment)6.562.55
Genotonorm 1.4 (Intermittent Treatment)4.372.16
Secondary outcomeMean· Baseline, 1 to 6 years, final height

Height (cm)

GroupValue (cm)Spread
Genotonorm 0.7 (Continuous Treatment)105.2215.04
Genotonorm 1.4 (Continuous Treatment)107.0612.29
Genotonorm 1.4 (Intermittent Treatment)106.4412.04
Secondary outcomeMean· Baseline, 1 to 6 years, final height

Change From Baseline in Height (cm)

GroupValue (cm)Spread
Genotonorm 0.7 (Continuous Treatment)8.211.38
Genotonorm 1.4 (Continuous Treatment)9.211.45
Genotonorm 1.4 (Intermittent Treatment)7.331.32
Secondary outcomeMean· Baseline, 1 to 6 years, final height

Height (SDS)

GroupValue (SDS)Spread
Genotonorm 0.7 (Continuous Treatment)-3.160.52
Genotonorm 1.4 (Continuous Treatment)-3.070.46
Genotonorm 1.4 (Intermittent Treatment)-3.210.65
Secondary outcomeMean· Baseline, 1 to 6 years, final height

Change From Baseline in Height (SDS)

GroupValue (SDS)Spread
Genotonorm 0.7 (Continuous Treatment)0.670.28
Genotonorm 1.4 (Continuous Treatment)0.880.30
Genotonorm 1.4 (Intermittent Treatment)0.530.28
Secondary outcomeMean· Baseline, 1 to 6 years

Body Mass Index (BMI)

GroupValue (kg/m^2)Spread
Genotonorm 0.7 (Continuous Treatment)14.741.48
Genotonorm 1.4 (Continuous Treatment)15.141.76
Genotonorm 1.4 (Intermittent Treatment)14.591.51

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Genotonorm 0.7 (Continuous Treatment)Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram \[mg\]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.–0 / 6840 / 68
Genotonorm 1.4 (Continuous Treatment)Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.–4 / 7042 / 70
Genotonorm 1.4 (Intermittent Treatment)Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.–3 / 6835 / 68

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 12 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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