NCT00660335已完成3 期
Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)- Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects With a History of Acute or Acute Recurrent Pancreatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •History of pancreatitis
- •Medically stable
- •Able to give informed consent
排除标准
- •Prior history of pancreatic resection
- •Prior history of pancreatic duct drainage procedure
- •Presence of a pancreatic stent
- •Unstable cardiovascular disease
- •Any contraindication to MRI procedure
- •Pregnancy
研究组 & 干预措施
1
Experimental
干预措施: RG1068 (synthetic human secretin) (Drug)
结局指标
主要结局
The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.
时间窗: 0 - 10 minutes post dose
次要结局
- The secondary outcome measure will assess safety(up to 30 days)
研究者
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