A Single-Center, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
研究概览
简要总结
This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aprepitant
Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
干预措施: Aprepitant (Drug)
Placebo
Subjects will receive one placebo tablet daily for 5 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
时间窗: Day 5, approximately 15 minutes after radioactive marker is administered
Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
Satiation Expressed as Volume to Fullness
时间窗: Day 4, approximately 30 minutes after liquid meal
Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
时间窗: Day 3, approximately 2 hours after radiolabeled meal is ingested
The time for half of the ingested solids to leave the stomach.
Accommodation Volume as Measured by SPECT
时间窗: Day 5, approximately 30 minutes after liquid meal
This variable is calculated as postprandial gastric volume minus fasting volume.
Postprandial Gastric Volume as Measured by SPECT
时间窗: Day 5, approximately 30 minutes after liquid meal
At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
次要结局
- Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours(Day 3, approximately 2 hours after radiolabeled meal is ingested)
- Maximum Tolerated Volume on Satiation Test(Day 4, approximately 30 minutes after liquid meal)
- Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test(Day 4, approximately 30 minutes after liquid meal)
- Aggregate Symptoms Score(Day 4, approximately 1 hour after liquid meal)
- Absolute postprandial gastric volume(Day 5, approximately 1 hour after radioactive marker is administered)
- Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours(Day 3, approximately 4 hours after radiolabeled meal is ingested)
- Gastric Volume Ratio(Day 5, approximately 1 hour after radioactive marker is administered)
研究者
Michael Camilleri, MD
Professor, College of Medicine
Mayo Clinic