NCT00296582已完成不适用
Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fasting and postprandial gastric volumes (Gastric accommodation)
研究概览
简要总结
This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dyspeptic Subjects:
- •Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year.
- •A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc).
- •No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years.
- •All Subjects:
- •No history suggestive of small bowel obstruction.
排除标准
- •No structural or metabolic diseases/conditions that affect the gastrointestinal system.
- •Unable to stop medications 48 hours prior to the study that:
- •Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- •Analgesic drugs including opiates, NSAID, COX 2 inhibitors
- •Systemic antifungal drugs
- •Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice.
- •Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- •Female subjects who are pregnant or breast feeding.
- •Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
- •Subjects who have participated in another clinical study within the past 30 days.
- •Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).
结局指标
主要结局
Fasting and postprandial gastric volumes (Gastric accommodation)
次要结局
- T1/2 of gastric emptying of solid
- Maximum tolerated volume
- Individual postprandial symptom scores
研究者
研究点 (1)
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