Gastro-oesophageal reflux disease (GORD)
Conditions
Interventions
Trade Name: Gaviscon Advance Peppermint
Product Name: Gaviscon Advance Peppermint Flavour
Product Code: PL 00063/0103
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Sodium Alginate
CAS Numb
Sponsors
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to confirm that Gaviscon Advance: (1) will not impair the sensitivity of pH-impedance monitoring (2) will suppresses both non-acid and acid reflux (distal and proximal reflux events) assessed by pH-impedance over a 4 hour period after a standardized test meal and over 24hr ambulatory monitoring (3) reduces the presence of pepsin in expectorated saliva 4 hours after a test meal The effects of ‘Gaviscon Advance’ will be compared to another over-the-counter antacid (Milk of Magnesia) that does not exhibit raft forming properties (a characteristic unique to Gaviscon Advance in which a roof is formed above gastric contents thereby preventing reflux).;Secondary Objective: No secondary efficacy parameters will be recorded.;Primary end point(s): The primary endpoint is the number of reflux episodes (acid and non-acid) during the 4 hr postprandial period following ingestion of 10ml Gaviscon Advance or Milk of Magnesia, two commonly used, over-the-counter, safe antacids. | — |
Countries
United Kingdom
Outcome results
None listed