A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00638053

Purpose

The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury

Condition	Intervention	Phase
Brain Injuries Growth Hormone Deficiency Dwarfism	Genetic: somatropin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism Injuries Traumatic Brain Injury Wounds

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
Number of patients with abnormal GH stimulation tests [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in waist circumference [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Age and gender specific optimal doses of GH replacement [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
Assessment of adverse events [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Change from baseline in Glasgow Outcome Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Change in Quality of Life-Mini-Mental scores [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2002
Study Completion Date:	November 2003

Arms	Assigned Interventions
1: Experimental	Genetic: somatropin Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months

Arms

Assigned Interventions

1: Experimental

Genetic: somatropin

Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months

Detailed Description:

The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented GHD
Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)

Exclusion Criteria:

Active systemic malignancy or active intracranial tumor
Growth hormone replacement therapy in the last 12 months
History of dementia unrelated to traumatic brain injury

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638053

Locations

United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Pfizer Investigational Site
El Paso, Texas, United States, 79925
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Washington
Pfizer Investigational Site
Federal Way, Washington, United States, 98003

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

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	GENGHD-0018-078
Study First Received:	March 11, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00638053 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dwarfism
Craniocerebral Trauma
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Endocrine System Diseases

Trauma, Nervous System
Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Hypopituitarism
Bone Diseases, Developmental
Brain Injuries

ClinicalTrials.gov processed this record on February 08, 2010