Official Title: “Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury”

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 treatment of GHD caused by trauma or head injury

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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 for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Intervention(s) in this Clinical Trial

• Genetic: somatropin
  • Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline
  • Time Frame: Months 1 thru 11
    Safety Issue?: No
• Number of patients with abnormal GH stimulation tests
  • Time Frame: Baseline
    Safety Issue?: No

Secondary Measures

• Change from baseline in waist circumference
  • Time Frame: Month 12
    Safety Issue?: No
• Age and gender specific optimal doses of GH replacement
  • Time Frame: Months 1 thru 11
    Safety Issue?: No
• Change in Quality of Life-Adult Growth Hormone Deficiency Assessment
  • Time Frame: Months 1 thru 12
    Safety Issue?: No
• Assessment of adverse events
  • Time Frame: Months 1 thru 12
    Safety Issue?: No
• Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies
  • Time Frame: Baseline
    Safety Issue?: No
• Change from baseline in Glasgow Outcome Score
  • Time Frame: Month 12
    Safety Issue?: No
• Change in Quality of Life-Mini-Mental scores
  • Time Frame: Months 1 thru 12
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• Active systemic malignancy or active intracranial tumor
• Growth hormone replacement therapy in the last 12 months
• History of dementia unrelated to traumatic brain injury

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638053

Study ID Number: GENGHD-0018-078

ClinicalTrials.gov Identifier: NCT00638053

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting: