Clinical trial NCT00555009: Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Official title: Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Brain Injuries
Growth Hormone Deficiency
Keywords: traumatic brain Injury, cognitive function
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Change From Baseline in CogState™ at Week 12 and 24.
timeFrame: Baseline, Week 12 and 24
measure: Change From Baseline in Lean Body Mass and Fat Mass at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in Cardiovascular Risk
timeFrame: Baseline, Weeks 2, 4, 12, 24, and 36
measure: Change From Baseline in Weight
timeFrame: Baseline, Weeks 2, 4, 12, 24, and 36
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, Weeks 2, 4, 12, 24, and 36
Other outcomes:
Locations:
city: Creteil Cedex
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Göteborg
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Salford
country: United Kingdom
facility: Pfizer Investigational Site
state: Manchester
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: