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

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.
 
ClinicalTrials.gov Identifier: NCT00174421
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 3, 2007
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Growth Disorder Drug: Treatment with Genotropin in different dosages Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
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
Study Start Date : April 2001
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Final height, compared to the expected familial target height

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00174421    
Other Study ID Numbers: 98-8122-011
A6281219
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes