NCT00171613已完成4 期
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 32
- 主要终点
- Change from baseline in BMI
研究概览
简要总结
The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient must provide written informed consent
排除标准
- •Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403
- •Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol
- •Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot
- •Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion & exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol.
- •Other protocol-defined inclusion / exclusion criteria may apply.
结局指标
主要结局
Change from baseline in BMI
次要结局
- Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat
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