Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
- Registration Number
- NCT02989467
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects will receive one placebo tablet daily for 5 consecutive days. Aprepitant 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.
- Primary Outcome Measures
Name Time Method Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours Day 3, approximately 2 hours after radiolabeled meal is ingested On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.
Maximum Tolerated Volume on Satiation Test Day 4, approximately 30 minutes after liquid meal On Day 4, subjects will do a satiation/nutrient drink test. Participants 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 5.
Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test Day 4, approximately 30 minutes after liquid meal Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end.
Aggregate Symptoms Score Day 4, approximately 1 hour after liquid meal Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).
Absolute postprandial gastric volume Day 5, approximately 1 hour after radioactive marker is administered This is the total postprandial gastric volume
Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours Day 3, approximately 4 hours after radiolabeled meal is ingested On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.
Gastric Volume Ratio Day 5, approximately 1 hour after radioactive marker is administered Postprandial/fasting gastric volume
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States