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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


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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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