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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Genotonorm

About this trial

This is an interventional treatment trial for Growth Disorders focused on measuring Short height, intra-uterine growth retardation, Genotonorm, continuous treatment, intermittent treatment

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Genotonorm A

Genotonorm B

Genotonorm C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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}

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Body Mass Index (BMI)

BMI was calculated by weight divided by height squared.

Weight

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

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.

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.

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.

Full Information

NCT ID

NCT01073605

First Posted

February 22, 2010

Last Updated

November 8, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01073605

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

July 1993 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Growth Disorders, Intrauterine Growth Retardation

Keywords

Short height, intra-uterine growth retardation, Genotonorm, continuous treatment, intermittent treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genotonorm A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Genotonorm B

Arm Type

Active Comparator

Arm Description

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

Arm Title

Genotonorm C

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Genotonorm

Intervention Description

0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Genotonorm

Intervention Description

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Genotonorm

Intervention Description

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Primary Outcome Measure Information:

Title

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

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}

Time Frame

Baseline, 2 years

Secondary Outcome Measure Information:

Title

Annual Growth Rate Standard Deviation Score (SDS)

Description

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

Time Frame

Baseline, 1 to 6 years

Title

Change From Baseline in Annual Growth Rate SDS

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.

Time Frame

Baseline, 1 to 3 years

Title

Height (cm)

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.

Time Frame

Baseline, 1 to 6 years, final height

Title

Change From Baseline in Height (cm)

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.

Time Frame

Baseline, 1 to 6 years, final height

Title

Height (SDS)

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.

Time Frame

Baseline, 1 to 6 years, final height

Title

Change From Baseline in Height (SDS)

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.

Time Frame

Baseline, 1 to 6 years, final height

Title

Body Mass Index (BMI)

Description

BMI was calculated by weight divided by height squared.

Time Frame

Baseline, 1 to 6 years

Title

Weight

Time Frame

Baseline, 1 to 6 years

Title

Change From Baseline in Bone Age

Description

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

Time Frame

Baseline, 1 to 3 years

Title

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

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.

Time Frame

1 to 3 years

Title

Chronological Age at Onset of Puberty

Description

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

Time Frame

Onset of puberty

Title

Number of Subjects Reaching Puberty

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.

Time Frame

Baseline, 1 to 6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Amiens

ZIP/Postal Code

80030

Country

France

Facility Name

Pfizer Investigational Site

City

Angers cedex

ZIP/Postal Code

49933

Country

France

Facility Name

Pfizer Investigational Site

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Pfizer Investigational Site

City

Boulogne

ZIP/Postal Code

92100

Country

France

Facility Name

Pfizer Investigational Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Pfizer Investigational Site

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Pfizer Investigational Site

City

Clermont Ferrand

ZIP/Postal Code

63000

Country

France

Facility Name

Pfizer Investigational Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Pfizer Investigational Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Pfizer Investigational Site

City

Hyères

ZIP/Postal Code

83407

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Pfizer Investigational Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Pfizer Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75674

Country

France

Facility Name

Pfizer Investigational Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Pfizer Investigational Site

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Priest en Jarez

ZIP/Postal Code

42277

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg Cedex 2

ZIP/Postal Code

67098

Country

France

Facility Name

Pfizer Investigational Site

City

Tarbes

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse Cedex

ZIP/Postal Code

31026

Country

France

Facility Name

Pfizer Investigational Site

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Pfizer Investigational Site

City

Vandoeuvre Les Nancy Cedex

ZIP/Postal Code

54511

Country

France

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=93-8122-001&StudyName=Genotropin%20Treatment%20in%20Short%20Prepubertal%20Children%20with%20Intra-Uterine%20Growth%20Retardation

Description

To obtain contact information for a study center near you, click here.

Growth Disorders, Intrauterine Growth Retardation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial