An assessment of combined pH-impedance monitoring for clinical studies of 'Gaviscon Advance®' in gastro-oesophageal reflux disease

Guy's and St Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 20 人开始时间: 2010年6月9日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Aged between 18 and 65 years, either sex
•2. History of reflux symptoms (heartburn, acid regurgitation, chest pain) requiring referral for oesophageal manometry and pH studies
•3. 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
•4. Provision of written, fully informed consent to undergo mechanistic study procedures

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

发起方

Guy's and St Thomas' NHS Foundation Trust (UK)