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
  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:


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
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: 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 October 21, 2014