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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: August 4, 2008
Last verified: August 2008
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: 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

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00174278

Pfizer Investigational Site
Paris, France
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00174278     History of Changes
Other Study ID Numbers: 96-8123-018
Study First Received: September 9, 2005
Last Updated: August 4, 2008

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on June 23, 2017