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

NCT01073605 | Completed Phase 3 Results

• 2 other identifiers: 93-8122-001A6281186, CTN 93-8122-001
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Growth Disorders; Intrauterine Growth Retardation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Annual Growth Rate Standard Deviation Score (SDS)

  Baseline, 1 to 6 years

• Change From Baseline in Annual Growth Rate SDS

  Baseline, 1 to 3 years

• Height (cm)

  Baseline, 1 to 6 years, final height

• Change From Baseline in Height (cm)

  Baseline, 1 to 6 years, final height

• Height (SDS)

  Baseline, 1 to 6 years, final height

Study Arms (3)

Genotonorm A

ACTIVE COMPARATOR

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

Drug: Genotonorm

Genotonorm B

ACTIVE COMPARATOR

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

Drug: Genotonorm

Genotonorm C

ACTIVE COMPARATOR

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

Drug: Genotonorm

Interventions

Genotonorm DRUG

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

Genotonorm A

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Endocrine disease except well-substituted hypothyroidism
• Sever chronic disease
• Skeletal dysplasia
• Known chromosomal aberration
• Ongoing treatment with steroids
• Known intrauterine infection

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Pfizer Investigational Site

Angers, France, 49933, France

Location

Pfizer Investigational Site

Grenoble, France, 38043, France

Location

Pfizer Investigational Site

Paris, France, 75674, France

Location

Pfizer Investigational Site

Amiens, 80030, France

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Bordeaux, 33076, France

Location

Pfizer Investigational Site

Boulogne, 92100, France

Location

Pfizer Investigational Site

Brest, 29200, France

Location

Pfizer Investigational Site

Bron, 69677, France

Location

Pfizer Investigational Site

Clermont-Ferrand, 63000, France

Location

Pfizer Investigational Site

Dijon, 21034, France

Location

Pfizer Investigational Site

Grenoble, 38043, France

Location

Pfizer Investigational Site

Hyères, 83407, France

Location

Pfizer Investigational Site

Lille, 59000, France

Location

Pfizer Investigational Site

Lille, 59037, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Montpellier, 34059, France

Location

Pfizer Investigational Site

Nantes, 44093, France

Location

Pfizer Investigational Site

Nice, 06202, France

Location

Pfizer Investigational Site

Paris, 75019, France

Location

Pfizer Investigational Site

Paris, 75571, France

Location

Pfizer Investigational Site

Reims, 51092, France

Location

Pfizer Investigational Site

Rennes, 35033, France

Location

Pfizer Investigational Site

Rouen, 76000, France

Location

Pfizer Investigational Site

Saint-Priest-en-Jarez, 42277, France

Location

Pfizer Investigational Site

Strasbourg, 67098, France

Location

Pfizer Investigational Site

Tarbes, France

Location

Pfizer Investigational Site

Toulouse, 31026, France

Location

Pfizer Investigational Site

Tours, 37044, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

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

MeSH Terms

Conditions

Growth Disorders; Fetal Growth Retardation

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: July 1, 1993
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 18, 2010
• Results First Posted: August 31, 2010

Record last verified: 2010-02

Locations

FR (31)