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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00638053 |
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Date of registration:
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11/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00638053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency Dwarfism
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Brain Injuries
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Intervention(s)
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Genetic: somatropin
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Primary Outcome(s)
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Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline
[Time Frame: Months 1 thru 11]
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Number of patients with abnormal GH stimulation tests
[Time Frame: Baseline]
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Secondary Outcome(s)
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Age and gender specific optimal doses of GH replacement
[Time Frame: Months 1 thru 11]
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Assessment of adverse events
[Time Frame: Months 1 thru 12]
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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]
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Change from baseline in waist circumference
[Time Frame: Month 12]
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Change in Quality of Life-Adult Growth Hormone Deficiency Assessment
[Time Frame: Months 1 thru 12]
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Change from baseline in Glasgow Outcome Score
[Time Frame: Month 12]
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Change in Quality of Life-Mini-Mental scores
[Time Frame: Months 1 thru 12]
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Secondary ID(s)
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GENGHD-0018-078
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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