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

NCT00638053 Phase 4 TERMINATED

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

Details

Lead sponsor	Pfizer
Phase	Phase 4
Status	TERMINATED
Enrolment	100
Start date	2002-11
Completion	2003-11

Conditions

• Brain Injuries
• Growth Hormone Deficiency Dwarfism

Interventions

• somatropin

Primary outcomes

• 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

Countries

United States