Gaviscon Double Action vs placebo study

• Research type

  Research Study

• Full title

  A randomised, double blind placebo controlled study in patients with reflux symptoms to assess suppression of gastro-oesophageal reflux by ‘Gaviscon Double Action Peppermint liquid’ using the BRAVO system

• IRAS ID

  59366

• Contact name

  Terry Wong

• Sponsor organisation

  Reckitt Benckiser

• Eudract number

  2010-021630-63

• ISRCTN Number

  ISRCTN52169198

• Research summary

  Symptoms of gastrooesophageal reflux disease (GORD) are very common in the community and have important, adverse effects on patient health and quality of life. Reflux 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) reflux episodes, especially after a meal. Studies using combined pH-impedance monitoring have shown that persistent weakly acid reflux events are a common cause for ongoing symptoms. Furthermore PPIs have no effect on the reflux of other noxious substances produced in the stomach (e.g. pepsin) which have been implicated in GORD complications. Therefore alternative methods to suppress all reflux 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 reflux events and reduce GORD symptoms. Gaviscon Double Action Peppermint is a liquid product containing antacid and alginate components which treats heartburn and indigestion.It acts as an antacid while providing a protective barrier which prevents reflux of stomach acid, which in turn prevents symptoms. To date, it is unknown how effective Gaviscon Double Action is with regard to reflux suppression. Therefore, the aim of this pilot study is to assess reflux suppression of Gaviscon Double Action compared to a closely matched Placebo. This study will also provide a basis formsample size calculation for future studies. Wireless pH-monitoring will be used as it is the most advanced technique for assessment of GORD and is better tolerated than catheter-based methods.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/89

• Date of REC Opinion

  8 Feb 2011

• REC opinion

  Further Information Favourable Opinion