A Multi-center, Open-label Comparison Study of a 13C-uracil Breath Test Versus 99mTechnetium Sulfur Colloid Gastric Emptying Scintigraphy to Evaluate Normal, and Delayed Gastric Emptying Time in Dyspeptic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Expired 13CO2 concentrations
研究概览
简要总结
This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.
详细描述
Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.
The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index [range is 18.0 to 33.0 kg/m2
- •Subjects with any upper GI symptoms
- •Stable creatinine
排除标准
- •History of known peptic ulcers or stomach cancer.
- •History of stomach surgery or resection
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food or other substance, unless approved by the investigator
- •History of alcoholism or drug abuse
- •History or presence of clinically significant GI, cardiovascular, central nervous system, hepatic, or renal disease; or other conditions
- •History of eating disorders
- •History or presence of an abnormal ECG, which, in the opinion of the investigator, is clinically significant
研究组 & 干预措施
13C-uracil and 99mTc sulfur colloid
Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.
干预措施: 13C-uracil (Drug)
13C-uracil and 99mTc sulfur colloid
Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.
干预措施: 99mTc sulfur colloid (Drug)
99mTc sulfur colloid
Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.
干预措施: 99mTc sulfur colloid (Drug)
结局指标
主要结局
Expired 13CO2 concentrations
时间窗: 6 hours
Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)\[B\] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2\[B\] semi solid: half emptying time of semi-solid test meal , and tlag\[B\] semi-solid: lag time of semi-solid test meal.
次要结局
- Concentrations of 13C-uracil and its major metabolites in plasma and urine(6 hours)