Clinical trial NCT00638053: A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Brain Injuries
Growth Hormone Deficiency Dwarfism
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 treatment of GHD caused by trauma or head injury

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.

Eligibility 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

Primary outcomes:
measure: Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline
timeFrame: Months 1 thru 11
measure: Number of patients with abnormal GH stimulation tests
timeFrame: Baseline
Secondary outcomes:
measure: Change from baseline in waist circumference
timeFrame: Month 12
measure: Age and gender specific optimal doses of GH replacement
timeFrame: Months 1 thru 11
measure: Change in Quality of Life-Adult Growth Hormone Deficiency Assessment
timeFrame: Months 1 thru 12
measure: Assessment of adverse events
timeFrame: Months 1 thru 12
measure: 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
timeFrame: Baseline
measure: Change from baseline in Glasgow Outcome Score
timeFrame: Month 12
measure: Change in Quality of Life-Mini-Mental scores
timeFrame: Months 1 thru 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: