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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174278
First Posted: September 15, 2005
Last Update Posted: August 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00174278     History of Changes
Other Study ID Numbers: 96-8123-018
A6281217
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: August 5, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs