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临床试验/EUCTR2010-019072-68-GB
EUCTR2010-019072-68-GB进行中(未招募)不适用

A randomised, double blind, crossover study to determine the mechanism of action of Gaviscon Advance in Gastro-Oesophageal Reflux Disease (GORD) - Gaviscon Advance

Guy's & St Thomas' NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2010年12月13日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Between 18 and 65 years of age
  • -History of reflux symptoms (heartburn, acid regurgitation, chest pain) requiring referral for oesophageal manometry and pH studies.
  • -Patients with chronic cough or dental problems are not excluded from the trial; however typical reflux symptoms must be present also. This is because there is little evidence that reflux events are responsible for symptoms in this group.31
  • -Provision of written, fully informed consent to undergo mechanistic study procedures
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • --Significant gastrointestinal symptoms or disease other than reflux
  • -Large hiatus hernia (>3cm)
  • -Severe reflux oesophagitis or Barrett’s oesophagus on endoscopy (LA grade III-IV).
  • -Previous upper GI surgery or interventions such as oesophageal dilatations
  • -Predominant symptoms of motility disorders, e.g. dysphagia
  • -Presence of major oesophageal dysmotility on manometry, e.g. achalasia, diffuse spasm, aperistalsis (>80% swallows)
  • -Significant co-morbidity requiring ongoing treatment or investigation
  • -Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility)
  • -Pregnancy or lactation at the time of enrolment

研究者

发起方
Guy's & St Thomas' NHS Foundation Trust

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