Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Injuries
Intervention: Genotropin (PN-180,307) Somatropin (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To establish the effects of genotropin replacement in patients with severe growth hormone
deficiency after traumatic brain injury on cognitive function.
Clinical Details
Official title: Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
Secondary outcome: Change CogState™ at Week 12, 24, 60 and 72.
Change in lean body mass and fat mass at Week 36 and 72.
Change in the Extended Glasgow Outcome Scale at week 36 and 72.
Change in quality of life at week 24, 36, 60 and 72.
Summary of change in cardiovascular
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Last updated: May 15, 2007
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