NCT00630487终止3 期
Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
研究概览
简要总结
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
详细描述
The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 65 years of age
- •Isolated growth hormone deficiency
排除标准
- •Isolated growth hormone deficiency by childhood onset
- •Diabetes mellitus type 1 or 2
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Verum
Active Comparator
干预措施: Somatropin (Drug)
结局指标
主要结局
Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
时间窗: Baseline, 52 weeks
Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.
次要结局
- Change in Visceral Fat Mass in Subgroups(Baseline, 52 weeks, 78 weeks)
- Change From Baseline in Anthropometric Parameters (Height)(Baseline, 52 weeks, 78 weeks)
- Change From Baseline in Anthropometric Parameters (Weight)(Baseline, 52 weeks, 78 weeks)
- Change From Baseline in Anthropometric Parameters (Waist Circumference)(Baseline, 52 weeks, 78 weeks)
- Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])(Baseline, Week 52, Week 78)
- Change From Baseline in Blood Pressure(Baseline, Week 52, Week 78)
- Change From Baseline in Heart Rate(Baseline, Week 52, Week 78)
- Change in Executive Function and Memory in Subgroups(Baseline, Week 52, Week 78)
- Change From Baseline in Safety Laboratory Assessments(Baseline, Week 52, Week 78)
- Change From Baseline in Homeostasis Model Assessment (HOMA)-Index(Baseline, Week 52, Week 78)
- Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)(Baseline, Week 52, Week 78)
- Change From Baseline in Short Form (36) Health Survey (SF36)(Baseline, Week 52, Week 78)
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)(Baseline, Week 52, Week 78)
- Change From Baseline in Cardiovascular Risk Factors(Baseline, Week 52, Week 78)
研究者
研究点 (1)
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