Sodium Alginate Chewable Tablet European Symptom Relief Study
Research type
Research Study
Full title
A multi-centre, randomised, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on symptoms of gastro-oesophageal reflux disease.
IRAS ID
176906
Contact name
Alan G Wade
Contact email
Sponsor organisation
Reckitt Benckiser Healthcare UK Ltd
Eudract number
2014-005261-69
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
Gastro-oesophageal reflux disease (GORD)is characterised with the symptoms of dyspepsia (referred to by the non-medical term indigestion) heartburn and regurgitation. Sodium alginate chewable tablets have been developed to provide benefit by treating the symptoms of both heartburn and indigestion.
To date the only GORD symptom studies conducted have been an exploratory study in the Western population and a large therapeutic confirmatory study in Chinese mainland patients.
The plan is to investigate the effect of the medication on GORD symptoms in a Western population and generate additional evidence of efficacy and safety in a robust study design. It is multi-centre, having sites in the UK, Italy and Germany, double-blind and randomized to treatment with study drug or placebo.
Participation will involve 3 visits to the clinic with a 7-10 day treatment period and at screening assessments will include an ECG, routine blood tests and endoscopy to determine the subject's gastric status and appropriateness for treatment in the study. Subjects will be asked to keep a diary between visits and answer questionnaires on symptoms at each visit.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0071
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion