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Trial record 1 of 1 for:    NCT00555009
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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00555009
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 7, 2007
Results First Posted : June 2, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE November 7, 2007
Results First Submitted Date  ICMJE December 22, 2009
Results First Posted Date  ICMJE June 2, 2010
Last Update Posted Date June 2, 2010
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 [ Time Frame: Baseline, Week 36 ]
CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
The primary endpoint is the change from baseline in the CogState™ composite score. [ Time Frame: At Week 36 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
  • Change From Baseline in CogState™ at Week 12 and 24. [ Time Frame: Baseline, Week 12 and 24 ]
    CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.
  • Change From Baseline in Lean Body Mass and Fat Mass at Week 36 [ Time Frame: Baseline, Week 36 ]
    The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.
  • Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 [ Time Frame: Baseline, Week 36 ]
    The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery
  • Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 [ Time Frame: Baseline, Week 36 ]
    A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.
  • Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 [ Time Frame: Baseline, Week 36 ]
    The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 'Yes' or 'No' statements covering 6 dimensions - mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.
  • Change From Baseline in Cardiovascular Risk [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]
    The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).
  • Change From Baseline in Weight [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]
  • Change From Baseline in Waist Circumference [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • Change from baseline in CogState™. [ Time Frame: At Week 12 and 24 ]
  • Change from baseline in lean body mass and fat mass. [ Time Frame: At Week 36 ]
  • Change from baseline in neurological outcome as assessed by Extended Glasgow Outcome Scale. [ Time Frame: At week 36 ]
  • Change from baseline in quality of life [ Time Frame: At week 36. ]
  • Change from baseline in cardiovascular risk.
  • Change from baseline in weight and waist circumference.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Official Title  ICMJE Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
Brief Summary To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injuries
  • Growth Hormone Deficiency
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
Study Arms  ICMJE
  • Experimental: Genotropin treatment arm
    Intervention: Drug: Genotropin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: March 6, 2009)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2007)
120
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555009
Other Study ID Numbers  ICMJE A6281289
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 2009

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