Growth Retardation In Children With Special Pathological Conditions Or Disease - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00163215

Purpose

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Condition	Intervention	Phase
Endocrine System Diseases	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.

Resource links provided by NLM:

MedlinePlus related topics: Endocrine Diseases

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The main criterion of efficacy is the 12-month Growth rate in SD for chronological age (CA) the 3rd year after Visit 2. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the evolution of height under Growth Hormone (GH) treatment after 1, 2 and 3 years [ Time Frame: Month 18 and Month 36 ] [ Designated as safety issue: No ]
To estimate the growth rate 1 and 2 years after inclusion in the study [ Time Frame: Month 12 and Month 24 ] [ Designated as safety issue: No ]
To confirm the good clinical and biological safety of GH treatment in such children [ Time Frame: Baseline, Month 12, Month 18, Month 24, Month 36 ] [ Designated as safety issue: Yes ]

Enrollment:	46
Study Start Date:	March 2005
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Somatropin	Drug: Somatropin Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years

Eligibility

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

Criteria

Inclusion Criteria:

Bone age < 13 years for a boy and < 11 years for a girl
Naive child: Measured Height < -2.5 SD for CA
Child currently treated by GH

Exclusion Criteria:

Idiopathic short stature
Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163215

Locations

France
Pfizer Investigational Site
Annemasse Cedex, France, 74107
Pfizer Investigational Site
Besancon, France, 25030
Pfizer Investigational Site
Bordeaux, France, 33000
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Bron Cedex, France, 69677
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Grenoble Cedex, France, 38043
Pfizer Investigational Site
Lorient, France, 56100
Pfizer Investigational Site
Lyon Cedex 05, France, 69322
Pfizer Investigational Site
Marseille, France, 13385
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris, France, 75571
Pfizer Investigational Site
Paris, France, 75674 Cedex
Pfizer Investigational Site
PRINGY Cedex, France, 74374
Pfizer Investigational Site
Toulouse Cedex, France, 31026
Pfizer Investigational Site
Vandoeuvre Les Nancy Cedex, France, 54511

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:	NCT00163215 History of Changes
Other Study ID Numbers:	A6281269
Study First Received:	September 9, 2005
Last Updated:	October 12, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012