Gaviscon liquid suspension as add-on therapy in GORD patients on PPI
Research type
Research Study
Full title
A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled pivotal study to assess the effect of a sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.
IRAS ID
170505
Contact name
Gordon Crawford
Contact email
Sponsor organisation
Reckitt Benckiser Healthcare (UK) Limited
Eudract number
2014-003174-17
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
This study is being conducted in male and female adult patients with inadequately controlled symptoms of heartburn, acid regurgitation and dyspepsia despite taking a proton pump inhibitor (PPI) treatment once daily, The purpose of this study is to provide evidence that a suspension of sodium alginate 50mg/ml, sodium bicarbonate 21.3 mg/ml, and calcium carbonate 32.5 mg/ml i.e. Gaviscon® Double Action Liquid Sachets (hereafter referred to as sodium alginate liquid suspension), can suppress the above mentioned Gastro-Oesophageal Reflux Disease (GORD) symptoms in these patients if used as an add-on therapy to their once daily PPI treatment.
The study will determine changes from baseline in those symptoms considered most
important in GORD (heartburn and regurgitation) rather than general global assessments of GORD, using the HRDQ (Heartburn Regurgitation and Dyspepsia Questionnaire instrument. In addition, the weekly RDQ™ (Regurgitation and Dyspepsia Questionnaire) instrument will be used to support this approach.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0004
Date of REC Opinion
24 Mar 2015
REC opinion
Further Information Favourable Opinion