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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174408
First Posted: September 15, 2005
Last Update Posted: May 3, 2007
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.
Information provided by:
Pfizer
  Purpose
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 Intervention Phase
Growth Disorders Drug: Genotropin Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Height, height velocity

Secondary Outcome Measures:
  • Side effects

Estimated Enrollment: 110
Study Start Date: March 1990
Estimated Study Completion Date: February 2005
  Eligibility

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.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00174408     History of Changes
Other Study ID Numbers: 89-041
A6281048
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 3, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes