Effects of Esomeprazole on Gastric Emptying of Alcoholic Beverages, Blood Alcohol Concentrations, Gastroesophageal Reflux and Release of Some Gastrointestinal Hormones in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Gastric emptying time, gastroesophageal reflux
研究概览
简要总结
To investigate the effect of 20 mg esomeprazole daily for one week on gastric emptying of 500 ml beer, the consecutive blood alcohol levels, the gastroesophageal reflux and plasma levels of gastrin and CCK in a randomized, placebo-controlled, double-blinded manner in 16 healthy male volunteers.
Hypothesis:
The combined taking of esomeprazole and beer will inhibit gastric emptying as compared to the intake of beer alone. This will induce a delay of the ethanol absorption and of the consecutive blood ethanol concentrations. Gastric acid secretion after beer will be reduced after esomeprazole treatment. Therefore, gastroesophageal acid reflux will be reduced after the combined taking. We speculate that gastrin, but not CCK plasma levels, will be increased after the combined taking as compared to beer alone. Both, beer and PPIs, have stimulatory effects on gastrin release. However, the secretion of CCK from duodenal CCK-cells is inhibited when gastric emptying is prolonged.
详细描述
Sixteen healthy, male and non-smoking volunteers will be enrolled in this study. The subjects will be treated with placebo or with 20 mg esomeprazole daily for one week before gastric emptying will be determined. The sequence of the tests (verum or placebo) will be randomised in a cross over design. In each subject at most one test will be performed every 2 weeks to ensure one week without treatment (wash-out-phase) between both experiments.
All examinations will be performed in the afternoon. After a small breakfast in the morning subjects fast for at least 8 hours. During the examination, all subjects are sitting slightly leaned backwards. A double lumen nasogastric tube (Ch 14, Laboratories Pharmaceutiques Vygon, Ecouen, France) will be positioned in the most dependent part of the stomach and a pH-probe (F8/IR blue line, SME Medizintechnik, Weil am Rhein) will be positioned 5 cm above the lower esophageal sphincter. 500 ml beer will then be instilled into the stomach over 5 min. Gastric emptying will be determined every 10 min for 2 hours by ultrasonography.
Withdrawal criteria The trial can be stopped anytime by the volunteer without specified reasons or by the investigator in case of incompliance of the volunteer or subsequent incidence of exclusion criteria. In case of hypersensitive or allergic reaction against the medication or side effects of the medication, such as urtication, angioneurotic edema, vomiting, cardiovascular reaction (systolic blood pressure under 100 mm/Hg), paraesthesia, confusion, bronchial spasm or fever, the study will also be stopped.
In case of withdrawal of volunteers, up to four additional volunteers can be recruited to complete totalling 16 volunteers.
Assessment of safety Esomeprazole is a frequently administered drug in the therapy of particularly gastroesophageal reflux disease, gastritis and gastric or duodenal ulcers. Side effects are very rare, headache, abdominal pain, diarrhoea, bloating, nausea, vomiting and constipation are thereof the most frequent. The methods used in this study are clinical routine procedures and imply -if used by skilful physicians as in this study - no risk for complications.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included.
- •Before inclusion blood will be drawn and the following blood count, liver, pancreas, kidney, thyroid and coagulation parameters will be examined:
- •Creatinine (0.5 - 1.3 mg/dl),
- •Alc. Phosphatase (38 - 126 U/l),
- •GGT (0 - 85 U/l),
- •ALAT (0 - 50 U/l),
- •ASAT (0 - 37 U/l),
- •LDH (0 - 248 U/l),
- •Cholinesterase (>7000 U/l),
- •Amylase (25 - 130 U/l),
- •Lipase (114 - 300 U/l),
- •Leucocytes (3,5 - 11.0 10E9/L),
- •Erythrocytes (4.0 - 5.9 10E12/L),
- •Hb (12.0 - 17.5 g/dl),
- •Ht (33 - 50%),
- •Platelets (145 - 440 10E9/L),
- •CrP (< 10 mg/l),
- •TSH (0.4 - 5.0 mE/l),
- •fT4 (6 - 23 pmol/l),
- •INR (0.75 - 1.30),
- •PTT (15.0 - 33.0 sec.)
- •The results have to be within the physiological range (as given in parenthesis).
- •Moreover, volunteers have mentally to be able to understand the explanations concerning the study and follow to the instructions of the investigator.
排除标准
- •Any acute or chronic disease,
- •Heartburn more than once weekly,
- •Alcohol consumption of more than 50 g ethanol-equivalent per week,
- •Known hypersensitivity against esomeprazole,
- •Benzimidazole or other ingredients of the medication,
- •Fructose-intolerance,
- •Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency.
结局指标
主要结局
Gastric emptying time, gastroesophageal reflux
时间窗: 3h
次要结局
- blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms(3h)