Status:
WITHDRAWN
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
Lead Sponsor:
Pfizer
Conditions:
Brain Injuries
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00432263
Start Date
April 1 2007
Last Update
April 22 2015
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