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Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

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: NCT00174408
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 3, 2007
Information provided by:

Brief Summary:
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Condition or disease Intervention/treatment Phase
Growth Disorders Drug: Genotropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)
Study Start Date : March 1990
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Primary Outcome Measures :
  1. Height, height velocity

Secondary Outcome Measures :
  1. Side effects

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Birth length below -2 SD
  • Height at start below - 2 Sd

Exclusion Criteria:

  • Any endocrine or chronic disease
  • Any known syndrome with short stature

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): NCT00174408

Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Layout table for additonal information Identifier: NCT00174408    
Other Study ID Numbers: 89-041
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes