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
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 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 July 22, 2014