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Growth Retardation In Children With Special Pathological Conditions Or Disease
This study is currently recruiting participants.
Verified by Pfizer, October 2009
First Received: September 9, 2005   Last Updated: October 13, 2009   History of Changes
Sponsor: Pfizer
Information provided by: 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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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 ]

Estimated Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Somatropin: Experimental 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
France
Pfizer Investigational Site Active, not recruiting
PARIS, France, 75743
Pfizer Investigational Site Active, not recruiting
Besancon, France, 25030
Pfizer Investigational Site Recruiting
Paris, France, 75019
Pfizer Investigational Site Active, not recruiting
Grenoble Cedex, France, 38043
Pfizer Investigational Site Not yet recruiting
VANDOEUVRE LES NANCY, France, 54511
Pfizer Investigational Site Active, not recruiting
Bordeaux, France, 33000
Pfizer Investigational Site Active, not recruiting
Bordeaux, France, 33076
Pfizer Investigational Site Completed
Annemasse Cedex, France, 74107
Pfizer Investigational Site Active, not recruiting
Annecy, France, 74011
Pfizer Investigational Site Active, not recruiting
BRON CEDEX, France, 69677
Pfizer Investigational Site Not yet recruiting
STRASBOURG CEDEX 2, France, 67098
Pfizer Investigational Site Recruiting
Toulouse Cedex, France, 31026
Pfizer Investigational Site Active, not recruiting
Lyon Cedex 05, France, 69322
Pfizer Investigational Site Not yet recruiting
NANTES CEDEX 1, France, 44093
Pfizer Investigational Site Active, not recruiting
Montpellier, France, 34059
Pfizer Investigational Site Active, not recruiting
VANDOEUVRE LES NANCY CEDEX, France, 54511
Pfizer Investigational Site Active, not recruiting
Dijon, France, 21000
Pfizer Investigational Site Recruiting
Lorient, France, 56100
Pfizer Investigational Site Active, not recruiting
Paris, France, 75674 Cedex
Pfizer Investigational Site Recruiting
Marseille, France, 13385
Pfizer Investigational Site Active, not recruiting
Paris, France, 75571
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: A6281269
Study First Received: September 9, 2005
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00163215     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:
Endocrine System Diseases

ClinicalTrials.gov processed this record on November 09, 2009



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