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

• Conditions: Gastro-oesophageal reflux disease (GORD)

• Registration Number: EUCTR2010-019072-68-GB
• Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-13
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

-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

Exclusion Criteria

--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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified