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
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