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

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

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Hormones

Arms and Interventions
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Outcome Measures
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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.

Eligibility Criteria
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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
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
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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
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France
Pfizer Investigational Site
Paris, France
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00174278    
Other Study ID Numbers: 96-8123-018
A6281217
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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Dwarfism
Bone Diseases, Developmental
Bone Diseases
 Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases