A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

Condition(s) targeted: Brain Injuries; Growth Hormone Deficiency Dwarfism

Intervention: somatropin (Genetic)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

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

Primary outcome:

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline

Number of patients with abnormal GH stimulation tests

Secondary outcome:

Change from baseline in waist circumference

Age and gender specific optimal doses of GH replacement

Change in Quality of Life-Adult Growth Hormone Deficiency Assessment

Assessment of adverse events

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

Change from baseline in Glasgow Outcome Score

Change in Quality of Life-Mini-Mental scores

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15212, United States

Pfizer Investigational Site, El Paso, Texas 79925, United States

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States

Pfizer Investigational Site, Federal Way, Washington 98003, United States

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

Link to ClinicalStudyResults.org Posting:

Starting date: November 2002
Ending date: November 2003
Last updated: March 27, 2008