Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury (GHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00638053
Recruitment Status : Terminated (See reason for termination in detailed description.)
First Posted : March 18, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Brain Injuries Growth Hormone Deficiency Dwarfism Genetic: somatropin Phase 4

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2002
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [ Time Frame: Months 1 thru 11 ]
  2. Number of patients with abnormal GH stimulation tests [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Change from baseline in waist circumference [ Time Frame: Month 12 ]
  2. Age and gender specific optimal doses of GH replacement [ Time Frame: Months 1 thru 11 ]
  3. Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [ Time Frame: Months 1 thru 12 ]
  4. Assessment of adverse events [ Time Frame: Months 1 thru 12 ]
  5. 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 ]
  6. Change from baseline in Glasgow Outcome Score [ Time Frame: Month 12 ]
  7. Change in Quality of Life-Mini-Mental scores [ Time Frame: Months 1 thru 12 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638053


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00638053    
Other Study ID Numbers: GENGHD-0018-078
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism, Pituitary
Dwarfism
Brain Injuries
Craniocerebral Trauma
Endocrine System Diseases
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Genetic Diseases, Inborn