Status:
TERMINATED
A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury
Lead Sponsor:
Pfizer
Conditions:
Brain Injuries
Growth Hormone Deficiency Dwarfism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the ...
Detailed Description
The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis...
Eligibility Criteria
Inclusion
- Documented GHD
- Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)
Exclusion
- Active systemic malignancy or active intracranial tumor
- Growth hormone replacement therapy in the last 12 months
- History of dementia unrelated to traumatic brain injury
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00638053
Start Date
November 1 2002
End Date
November 1 2003
Last Update
April 1 2008
Active Locations (4)
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1
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
2
Pfizer Investigational Site
El Paso, Texas, United States, 79925
3
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
4
Pfizer Investigational Site
Federal Way, Washington, United States, 98003