Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00174187

Purpose

To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
To assess the effect of a long term treatment with Genotonorm on bone mineralisation
To assess the effect of a long term treatment with Genotonorm on body composition

Condition	Intervention	Phase
Endocrine System Diseases	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism Endocrine Diseases

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Growth velocity; Number of cm/year [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IGF-1: Insulinlike growth factor-1 [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
Evolution of bone metabolism by absorptiometry: Radiological test [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]
Evolution of body composition by DEXA: Dual X-ray absorptiometry [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	September 2000
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Somatropin	Drug: Somatropin liquide, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Detailed Description:

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children with juvenile arthritis or nephrotic syndrome
Before or during puberty

Exclusion Criteria:

Diabetes Type 1 and 2
Endocrine disease, except well substituted hypothyroidism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174187

Locations

France
Pfizer Investigational Site
Paris, France, 75743
Pfizer Investigational Site
Paris, France, 75019

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
ClinicalTrials.gov Identifier:	NCT00174187 History of Changes
Other Study ID Numbers:	307-MET-9002-0009, A6281016
Study First Received:	September 9, 2005
Last Updated:	November 30, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental

Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 09, 2012