NCT00638053终止4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented GHD
- •Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)
排除标准
- •Active systemic malignancy or active intracranial tumor
- •Growth hormone replacement therapy in the last 12 months
- •History of dementia unrelated to traumatic brain injury
结局指标
主要结局
Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline
时间窗: Months 1 thru 11
Number of patients with abnormal GH stimulation tests
时间窗: Baseline
次要结局
- Change from baseline in waist circumference(Month 12)
- Age and gender specific optimal doses of GH replacement(Months 1 thru 11)
- Change in Quality of Life-Adult Growth Hormone Deficiency Assessment(Months 1 thru 12)
- Assessment of adverse events(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(Baseline)
- Change from baseline in Glasgow Outcome Score(Month 12)
- Change in Quality of Life-Mini-Mental scores(Months 1 thru 12)
研究者
研究点 (5)
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