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

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ClinicalTrials.gov Identifier: NCT00174408
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 3, 2007
Sponsor:
Information provided by:
Pfizer

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

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
Drug Information available for: Somatropin
U.S. FDA Resources




Primary Outcome Measures :
  1. Height, height velocity

Secondary Outcome Measures :
  1. Side effects


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00174408


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00174408     History of Changes
Other Study ID Numbers: 89-041
A6281048
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes