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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174408
First received: September 12, 2005
Last updated: May 1, 2007
Last verified: May 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174408

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

No publications provided

ClinicalTrials.gov Identifier: NCT00174408     History of Changes
Other Study ID Numbers: 89-041, A6281048
Study First Received: September 12, 2005
Last Updated: May 1, 2007
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014