NCT03326518终止2 期
An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Lument AB
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Relative Mean Difference in Contrast Density
研究概览
简要总结
Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects of either gender at least 18 years at the time of signing the informed consent.
- •Having a clinical indication for CT-examination of the abdomen
排除标准
- •IV administration of iodine is contraindicated
- •Known allergy to egg albumen
- •Clinical suspicion, according to medical record, of fistula formation and/or leakage
- •Referral indication of small bowel disease(s)
- •Having known manifest thyrotoxicosis
- •Having known phenylketonuria
- •Having known Glucose-6-phosphatase deficiency
研究组 & 干预措施
Movprep®
Active Comparator
Contrast agent
干预措施: Movprep® (Diagnostic Test)
Lumentin® 44
Experimental
Contrast agent
干预措施: Lumentin® 44 (Diagnostic Test)
Diluted Omnipaque®
Active Comparator
Contrast agent
干预措施: Diluted Omnipaque® (Diagnostic Test)
结局指标
主要结局
Relative Mean Difference in Contrast Density
时间窗: Day 1
difference in contrast density between lumen and wall (mucosal lining)
次要结局
- Bowel Filling Properties, Distension(Day 1)
- Bowel Filling Properties, Extension(Day 1)
- Diagnostic Ability When Examining Abdominal CT(Day 1)
- Subjects' Assessment of Taste of the Contrast Agent(Day 1)
- Degradation of Contrast Agent (Lumentin® 44)(Day 1)
- Subjects' Assessment of Ability to Swallow the Contrast Agent(Day 1)
- Subjects' Assessment of Smell of the Contrast Agent(Day 1)
- Subjects' Assessment of Consistency of the Contrast Agent(Day 1)
- Subjects' Assessment of Fullness After Drinking the Contrast Agent(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Impact of Renalof® Dietary Supplement on Upper Urinary Tract Stone VolumeCalculus of Upper Urinary Tract (Disorder)NCT04860492Aristotle University Of Thessaloniki82
已完成
2 期
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant MelanomaNeoplasm MetastasisMelanomaNCT00055562Celgene Corporation274
已完成
3 期
Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR MutationsNSCLCNCT02759614Guangdong Association of Clinical Trials311
Unknown
3 期
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of TocilizumabCOVID-19 PneumoniaNCT05002517Biogipuzkoa Health Research Institute60
招募中
4 期
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.Unresectable Pancreatic CancerNCT06099119Hospital Clinico Universitario de Santiago100