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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00638053

Collaborator

(none)

100

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries Growth Hormone Deficiency Dwarfism	Genetic: somatropin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2002

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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

Arm

Intervention/Treatment

Experimental: 1

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

Outcome Measures

Primary Outcome Measures

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [Months 1 thru 11]
Number of patients with abnormal GH stimulation tests [Baseline]

Secondary Outcome Measures

Change from baseline in waist circumference [Month 12]
Age and gender specific optimal doses of GH replacement [Months 1 thru 11]
Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [Months 1 thru 12]
Assessment of adverse events [Months 1 thru 12]
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]
Change from baseline in Glasgow Outcome Score [Month 12]
Change in Quality of Life-Mini-Mental scores [Months 1 thru 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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