Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Brain Injuries

Growth Hormone Deficiency

Treatments

Drug: Genotropin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00555009

A6281289

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.
Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
Have proven GHD deficiency

Exclusion criteria

Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
History of dementia unrelated to TBI
History of benign intracranial hypertension