Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

NCT00174252 | Completed Phase 3 Results

• 1 other identifier: A6281234
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 22

Brief Summary

To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months

  Percentage of children with serum IGF-1 \> 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.

  9 and 12 months

Secondary Outcomes (19)

• Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

  Baseline, 12 months

• Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

  Baseline, 24 months

• Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months

  Baseline, 12 and 24 months

• Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

  Baseline, 12 months

• Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months

  Baseline, 24 months

Other Outcomes (6)

• Change in Height From Baseline

  Baseline, 12 and 24 months

• Growth Rate at 12 and 24 Months

  12 and 24 months

• Summary of Body Mass Index (BMI) at 12 and 24 Months

  12 and 24 months

Study Arms (1)

Genotonorm (Somatropin)

EXPERIMENTAL

Drug: Genotonorm (Somatropin)

Interventions

Genotonorm (Somatropin) DRUG

0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years

Genotonorm (Somatropin)

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
• Measured Height \< -2.5 Standard Deviation

You may not qualify if:

• Pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = B2 (Tanner)
• Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

Pfizer Investigational Site

Amiens, 80030, France

Location

Pfizer Investigational Site

Angers, 49000, France

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Bron, 69677, France

Location

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Dunkirk, 59385, France

Location

Pfizer Investigational Site

Lille, 59019, France

Location

Pfizer Investigational Site

Limoges, 87042, France

Location

Pfizer Investigational Site

Lorient, France

Location

Pfizer Investigational Site

Nice, 06202, France

Location

Pfizer Investigational Site

Paris, 75571, France

Location

Pfizer Investigational Site

Paris, 75743, France

Location

Pfizer Investigational Site

Paris, 75935, France

Location

Pfizer Investigational Site

Rennes, 35203, France

Location

Pfizer Investigational Site

Rouen, 76000, France

Location

Pfizer Investigational Site

Strasbourg, 67098, France

Location

Pfizer Investigational Site

Tarbes, 65000, France

Location

Pfizer Investigational Site

Toulouse, 31000, 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

Fetal Growth Retardation

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

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

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.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 15, 2010
• Results First Posted: June 4, 2010

Record last verified: 2009-06

Locations

FR (22)