A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
研究概览
简要总结
The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •The subject is over 18 years old.
- •Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.
排除标准
- •The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- •The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
- •The subject is pregnant.
- •The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- •The subject manifests thyrotoxicosis or is on dialysis.
研究组 & 干预措施
Arm 1-Iodixanol
干预措施: Iodixanol (Drug)
Arm 2-Iopamidol
干预措施: Iopamidol (Drug)
结局指标
主要结局
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
时间窗: Within 10 minutes post contrast administration
Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
时间窗: Within 10 minutes post contrast administration.
Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.
次要结局
- Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.(Ten minutes post contrast administration.)