Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonor

This study is currently recruiting participants.

Verified by Pfizer, July 2009

First Received: September 9, 2005 Last Updated: July 30, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00163189

Purpose

To estimate the evolution of height and growth rate over 3 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Condition	Intervention	Phase
Growth Hormone Deficiency	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evolution Of Growth Rate In Children With Growth Retardation Related To Long-Term Glucocorticosteroid Therapy and Treated By Genotonorm (Registered)

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Difference between height in standard deviation (SD) for chronological age (CA) after 3 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The outcome is the dosage of Insulinelike Growth Factor 1 (IGF1) in blood sample. [ Time Frame: Baseline, Month 12, Month 24, Month 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Somatropin: Experimental	Drug: Somatropin Liquide, daily, during 3 years Dosage: 0,46 mg/kg/week

Eligibility

Ages Eligible for Study:	11 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Glucocorticosteroid treatment for 12 months at least
Bone age < 13 years for a boy and < 11 years for a girl
Child measured height < - 2 SD, Child currently treated by GH

Exclusion Criteria:

Known diabetes (type 1 or type 2)
A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163189

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

France
Pfizer Investigational Site	Recruiting
Paris, France, 75019
Pfizer Investigational Site	Recruiting
Grenoble Cedex, France, 38043
Pfizer Investigational Site	Recruiting
Paris, France, 75743
Pfizer Investigational Site	Recruiting
Montpellier, France, 34090
Pfizer Investigational Site	Not yet recruiting
VANDOEUVRE LES NANCY, France, 54511
Pfizer Investigational Site	Recruiting
Annemasse Cedex, France, 74107
Pfizer Investigational Site	Active, not recruiting
BRON CEDEX, France, 69677
Pfizer Investigational Site	Recruiting
Toulouse Cedex, France, 31026
Pfizer Investigational Site	Active, not recruiting
Saint Germain en Laye, France, 78105
Pfizer Investigational Site	Recruiting
CLERMONT-FERRAND, France, 63058
Pfizer Investigational Site	Recruiting
Roscoff, France, 29684
Pfizer Investigational Site	Recruiting
Besancon, France, 25030
Pfizer Investigational Site	Recruiting
AMIENS, France, 80030
Pfizer Investigational Site	Recruiting
ROUEN CEDEX, France, 76031
Pfizer Investigational Site	Not yet recruiting
Dijon, France, 21000
Pfizer Investigational Site	Recruiting
PARIS CEDEX 12, France, 75571
Pfizer Investigational Site	Recruiting
Nice, France, 06200
Pfizer Investigational Site	Recruiting
Tours Cedex 1, France, 37044
Pfizer Investigational Site	Recruiting
Marseille, France, 13385
Pfizer Investigational Site	Recruiting
Nantes, France

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6281271
Study First Received:	September 9, 2005
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00163189 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Hypopituitary Dwarfism
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Growth Hormone Deficiency
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases

Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on September 11, 2009