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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:
ClinicalTrials.gov Identifier:
NCT00174421
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
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
Intervention Model: Parallel Assignment
Masking: None (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

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:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT00174421


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

ClinicalTrials.gov Identifier: NCT00174421     History of Changes
Other Study ID Numbers: 98-8122-011
A6281219
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