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Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174278
First received: September 9, 2005
Last updated: August 4, 2008
Last verified: August 2008
History of Changes
  Purpose

To assess the effect of long-term treatment by Genotonorm on linear growth


Condition Intervention Phase
Growth Hormone Deficiency
Growth Retardation
 Drug: Somatropin
 Phase 3

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®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Resource links provided by NLM:

MedlinePlus related topics: Dwarfism
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The main efficacy variable is the height SDS (SEMPE) before and after treatment.
  • The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
  • The height measurements are always performed at the same time of the day by
  • use of a wallmounted device (e.g. Harpenden Stadiometer).
  • Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
  • The body weight is measured by use of a balance scale.
  • Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Estimated Enrollment: 14
Study Start Date: February 1997
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
  • All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

  • Endocrine disease, except well substituted hypothyroidism
  • Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174278

Locations
France
Pfizer Investigational Site
Paris, 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

ClinicalTrials.gov Identifier: NCT00174278     History of Changes
Other Study ID Numbers: 96-8123-018, A6281217
Study First Received: September 9, 2005
Last Updated: August 4, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
 Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013