NCT00555009

Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Detailed description

The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Conditions

• Brain Injuries
• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Genotropin	Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
DRUG	Placebo	Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-11-07
• Last updated: 2010-06-02
• Results posted: 2010-06-02

Locations

9 sites across 6 countries: France, Italy, Netherlands, Spain, Sweden, United Kingdom