Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximal Concentration of Omerazole
研究概览
简要总结
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
详细描述
Hypothesis
Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.
Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.
Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"
- •Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.
- •Prior abnormal 4-hour gastric emptying scan within the past 3 years
排除标准
- •History of esophageal or gastric surgery
- •Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding jejunostomy tubes
- •Presence of gastric electrical stimulator
- •Symptoms of retching with vomiting more than 2 days per week
- •Diagnosis of diabetes
- •Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
- •Disorders of small bowel absorption
- •Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
- •Diagnosis of acid hypersecretory syndrome
- •Disorders affecting proton pump inhibitor metabolism (such as liver failure)
- •Known allergy or side effects to proton pump inhibitor
- •Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- •Pregnancy
研究组 & 干预措施
Immediate-release omeprazole release first
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
干预措施: Immediate-release omeprazole (Drug)
Immediate-release omeprazole release first
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
干预措施: Delayed-release omeprazole (Drug)
Delayed-release omeprazole first
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
干预措施: Immediate-release omeprazole (Drug)
Delayed-release omeprazole first
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
干预措施: Delayed-release omeprazole (Drug)
结局指标
主要结局
Maximal Concentration of Omerazole
时间窗: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
Maximal concentration of immediate-release vs. delayed-release omeprazole
Area Under the Curve for Omeprazole Plasma Concentration
时间窗: 0 to 5 hrs after the study drug was ingested on treatment day 7
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Time to Maximal Omeprazole Concentration (Tmax)
时间窗: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
Time to max concentration for Immediate release vs. Delayed release omeprazole
次要结局
未报告次要终点