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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

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