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

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. Identifier: NCT00174278
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 5, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Growth Retardation Drug: Somatropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 14 participants
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.
Study Start Date : February 1997
Actual Study Completion Date : October 2006

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00174278

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Pfizer Investigational Site
Paris, France
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00174278    
Other Study ID Numbers: 96-8123-018
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases