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

Brain Injuries Clinical Trial

— GHD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638053
• Other study ID #: GENGHD-0018-078
• Status: Terminated
• Phase: Phase 4
• First received: March 11, 2008
• Last updated: March 27, 2008
• Start date: November 2002
• Est. completion date: November 2003

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency Dwarfism

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	El Paso	Texas
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline		Months 1 thru 11	No
Primary	Number of patients with abnormal GH stimulation tests		Baseline	No
Secondary	Change from baseline in waist circumference		Month 12	No
Secondary	Age and gender specific optimal doses of GH replacement		Months 1 thru 11	No
Secondary	Change in Quality of Life-Adult Growth Hormone Deficiency Assessment		Months 1 thru 12	No
Secondary	Assessment of adverse events		Months 1 thru 12	No
Secondary	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		Baseline	No
Secondary	Change from baseline in Glasgow Outcome Score		Month 12	No
Secondary	Change in Quality of Life-Mini-Mental scores		Months 1 thru 12	No

External Links

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