Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Injuries; Growth Hormone Deficiency
Intervention: Genotropin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
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 on cognitive function in patients with
severe growth hormone deficiency after traumatic brain injury.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
Secondary outcome: Change From Baseline in CogState™ at Week 12 and 24.Change From Baseline in Lean Body Mass and Fat Mass at Week 36 Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 Change From Baseline in Cardiovascular Risk Change From Baseline in Weight Change From Baseline in Waist Circumference
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.
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 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
Locations and Contacts
Pfizer Investigational Site, Creteil Cedex 94010, France
Pfizer Investigational Site, Paris Cedex 13 75651, France
Pfizer Investigational Site, Ferrara 44100, Italy
Pfizer Investigational Site, Roma 00168, Italy
Pfizer Investigational Site, Rotterdam 3015 GD, Netherlands
Pfizer Investigational Site, Sevilla 41013, Spain
Pfizer Investigational Site, Göteborg 413 45, Sweden
Pfizer Investigational Site, Stockholm 171 76, Sweden
Pfizer Investigational Site, Salford, Manchester M6 8HD, United Kingdom
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2008
Last updated: June 1, 2010
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