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Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174421
First received: September 12, 2005
Last updated: May 1, 2007
Last verified: May 2007
History of Changes
  Purpose

This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age


Condition Intervention Phase
Growth Disorder
 Drug: Treatment with Genotropin in different dosages
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium

Resource links provided by NLM:

MedlinePlus related topics: Growth Disorders
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Final height, compared to the expected familial target height

Secondary Outcome Measures:
  • Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry

Estimated Enrollment: 36
Study Start Date: April 2001
Estimated Study Completion Date: August 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the 90-080 study

Exclusion Criteria:

  • Any severe, acute or chronic disease
  • Any other identifiable reason for short stature
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174421

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

No publications provided

ClinicalTrials.gov Identifier: NCT00174421     History of Changes
Other Study ID Numbers: 98-8122-011, A6281219
Study First Received: September 12, 2005
Last Updated: May 1, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013