Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Pfizer

Status and phase

Withdrawn

Phase 4

Conditions

Brain Injuries

Treatments

Drug: Genotropin (PN-180,307) Somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00432263

A6281274

Details and patient eligibility

About

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

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 5 years) prior to the screening visit.
Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

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.