Gaviscon Advance, version 1

• Research type

  Research Study

• Full title

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

• IRAS ID

  33369

• Sponsor organisation

  King's College London

• Eudract number

  2010-019072-68

• ISRCTN Number

  ISRCTN2875772

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Symptoms of gastro-oesophageal flu disease (GORD) are very common in the community and have important, adverse effects on patient health and quality of life. flu has also been linked to chronic cough, sore throat and other ear, nose and throat problems. Proton Pump Inhibitor (PPI) medications are the most common form of treatment. However up to 20% of patients have persistent symptoms probably because these PPIs do not reduce the frequency or proximal extent of weakly acid (pH 4-6) flu episodes, especially after a meal. Studies using combined pH-impedance monitoring have shown that persistent weakly acid flu events are a common cause for ongoing symptoms. Furthermore PPIs have no effect on the flu of other noxious substances produced in the stomach (e.g. pepsin) which have been implicated in GORD complications. Therefore alternative methods to suppress all flu events (not just acid) are required and surgery is not appropriate for many. Although alginate preparations have been shown to be effective in the short-term different preparations have different physical and chemical properties. Furthermore not all studies have confirmed that alginates suppress flu events and reduce GORD symptoms Gaviscon Advance is a safe and effective alginate which has a number of unique features that may protect the patient from both acid and non-acid flu. Better data is required to confirm its mechanism of action and especially its use in GORD patients for whom PPIs are either not appropriate or not effective. This project will provide an in-vivo assessment of advanced flu detection technologies while using Gaviscon Advance in GORD. Furthermore the mechanistic effectiveness of Gaviscon Advance after meals for suppressing acid and non-acid flu will be examined in those with typical flu symptoms. A novel pepsin assay will provide a direct assessment of pharyngeal exposure to gastric fluid.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/85

• Date of REC Opinion

  29 Oct 2010

• REC opinion

  Favourable Opinion