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临床试验/NCT03784105
NCT03784105已完成4 期

Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年9月7日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Codeine Phosphate (Drug)

Siripus simplex

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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