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Trial record 1 of 1 for:    NCT00638053
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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

Tracking Information
First Submitted Date  ICMJE March 11, 2008
First Posted Date  ICMJE March 18, 2008
Last Update Posted Date April 1, 2008
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
  • Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [ Time Frame: Months 1 thru 11 ]
  • Number of patients with abnormal GH stimulation tests [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00638053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
  • Change from baseline in waist circumference [ Time Frame: Month 12 ]
  • Age and gender specific optimal doses of GH replacement [ Time Frame: Months 1 thru 11 ]
  • Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [ Time Frame: Months 1 thru 12 ]
  • Assessment of adverse events [ Time Frame: Months 1 thru 12 ]
  • 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 ]
  • Change from baseline in Glasgow Outcome Score [ Time Frame: Month 12 ]
  • Change in Quality of Life-Mini-Mental scores [ Time Frame: Months 1 thru 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injuries
  • Growth Hormone Deficiency Dwarfism
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Intervention: Genetic: somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: March 11, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00638053
Other Study ID Numbers  ICMJE GENGHD-0018-078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP