Pilot Gaviscon Double Action pH monitoring study

• Research type

  Research Study

• Full title

  A single-centre, randomised, double-blind, two-way crossover, placebo-controlled pilot study, investigating the use of a novel intragastric and oesophageal pH catheter to characterise the antacid activity of Gaviscon Double Action Liquid in the fasted state followed by a preliminary investigation of the effects of food.

• IRAS ID

  94989

• Contact name

  Simon Singer

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd.

• Eudract number

  2011-004725-27

• Research summary

  Reckitt-Benckiser Healthcare Ltd. Wants to gain more information on the way Gaviscon Double Action Liquid affects acidity in the stomach and oesophagus. We will be using a novel probe, which can measure the pH at 11 different levels. We will also be assessing the suitability of this probe in studies like this and may use the information gained to work out how many people would need to be included in similar studies to give statistically meaningful results.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0018

• Date of REC Opinion

  24 Jan 2012

• REC opinion

  Further Information Favourable Opinion