Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid pocket‐targeting alginate–antacid (Gaviscon Double Action) – a double‐blind, placebo‐controlled, pilot study in gastro‐oesophageal reflux disease

Summary Background The alginate–antacid, Gaviscon Double Action (Gaviscon DA; Reckitt Benckiser, Slough, UK) suppresses reflux after meals by creating a gel‐like barrier that caps and displaces the acid pocket distal to the oesophago‐gastric junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design. Aim A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro‐oesophageal reflux disease ( GERD ) patients. Methods A randomised, double‐blind, parallel group study was performed in 110 patients with symptoms of GERD . Patients received Gaviscon DA or placebo tablets for 7 consecutive days. The primary endpoint compared the change in overall Reflux Disease Questionnaire ( RDQ ) symptom score (combined heartburn/regurgitation/dyspepsia). Secondary endpoints assessed individual dimensions, GERD dimension (heartburn and regurgitation) and overall treatment evaluation ( OTE ). Results There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group (Least Squares Mean difference −0.55; P  = 0.0033), and for each of the dimensions independently. Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34); P  = 0.0005]. No differences in the incidence of adverse events were observed between treatment groups. Conclusions Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit‐risk balance. Larger scale clinical investigations of medications targeting the acid pocket are warranted. (EudraCT, 2012‐002188‐84)