Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
研究概览
简要总结
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Have proven GHD deficiency
排除标准
- •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
研究组 & 干预措施
Genotropin treatment arm
干预措施: Genotropin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
时间窗: 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.
次要结局
- Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36(Baseline, Week 36)
- Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36(Baseline, Week 36)
- Change From Baseline in Weight(Baseline, Weeks 2, 4, 12, 24, and 36)
- Change From Baseline in CogState™ at Week 12 and 24.(Baseline, Week 12 and 24)
- Change From Baseline in Lean Body Mass and Fat Mass at Week 36(Baseline, Week 36)
- Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36(Baseline, Week 36)
- Change From Baseline in Cardiovascular Risk(Baseline, Weeks 2, 4, 12, 24, and 36)
- Change From Baseline in Waist Circumference(Baseline, Weeks 2, 4, 12, 24, and 36)