Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00555009

Purpose

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

Condition	Intervention	Phase
Brain Injuries Growth Hormone Deficiency	Drug: Genotropin Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is the change from baseline in the CogState™ composite score. [ Time Frame: At Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in neurological outcome as assessed by Extended Glasgow Outcome Scale. [ Time Frame: At week 36 ] [ Designated as safety issue: No ]
Change from baseline in weight and waist circumference. [ Time Frame: At 36 week ] [ Designated as safety issue: No ]
Change from baseline in quality of life [ Time Frame: At 36 weeks ] [ Designated as safety issue: No ]
Change from baseline in lean body mass and fat mass. [ Time Frame: At Week 36 ] [ Designated as safety issue: No ]
Change from baseline in cardiovascular risk. [ Time Frame: At 36 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in CogState™. [ Time Frame: At Week 12 and 24 ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	March 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Genotropin treatment arm: Experimental Not Specified	Drug: Genotropin Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
Placebo: Placebo Comparator	Drug: Placebo Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
History of benign intracranial hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555009

Locations

France
Pfizer Investigational Site
PARIS CEDEX 13, France, 75651
Pfizer Investigational Site
Creteil Cedex, France, 94010
Italy
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Ferrara, Italy, 44100
Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands, 3015 GD
Spain
Pfizer Investigational Site
SEVILLA, Spain, 41013
Sweden
Pfizer Investigational Site
Göteborg, Sweden, 413 45
Pfizer Investigational Site
Stockholm, Sweden, 171 76
United Kingdom, Manchester
Pfizer Investigational Site
Salford, Manchester, United Kingdom, M6 8HD

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6281289
Study First Received:	October 24, 2007
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00555009 History of Changes
Health Authority:	Italy: Agenzia Italiana del Farmaco (AIFA)

Keywords provided by Pfizer:

traumatic brain Injury, cognitive function

Additional relevant MeSH terms:

Craniocerebral Trauma
Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Wounds and Injuries
Disorders of Environmental Origin
Endocrine System Diseases

Central Nervous System Diseases
Trauma, Nervous System
Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Brain Injuries

ClinicalTrials.gov processed this record on November 27, 2009