Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Difference in distal contractile integral
研究概览
简要总结
Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between 18-60 years old
- •Written informed consent
排除标准
- •No chronic disease/medication
- •No GI symptoms
- •Not pregnant or breast-feeding
- •No history of head/neck surgery
- •Not allergic to codeine
研究组 & 干预措施
Codeine
干预措施: Codeine Phosphate (Drug)
Siripus simplex
干预措施: Siripus simplex (Drug)
结局指标
主要结局
Difference in distal contractile integral
时间窗: 1 week
The difference in distal contractile integral between the codeine and placebo condition
Difference in integrated relaxation pressure
时间窗: 1 week
The difference in integrated relaxation pressure between the codeine and placebo condition
Difference in distal latency
时间窗: 1 week
The difference in distal latency between the codeine and placebo condition.
Difference in pressure flow
时间窗: 1 week
The difference in pressure flow between the codeine and placebo condition
次要结局
未报告次要终点
