Pilot 3-way Gaviscon chewable tablets heartburn, meal, stopwatch study

• Research type

  Research Study

• Full title

  A single centre, randomised, partially-blind, placebo-controlled 3 way crossover pilot study investigating efficacy in terms of heartburn relief after taking (2x250mg) Gaviscon® chewable tablets, (1x20mg) Losec® MUPS® tablet and (2x) Placebo tablets in subjects with heartburn following a refluxogenic meal.

• IRAS ID

  45862

• Sponsor organisation

  Reckitt Benckiser Healthcare UK Ltd

• Eudract number

  2010-019414-24

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Gaviscon© is an alginate-based reflux suppressant that offers relief to those that suffer from heartburn symptoms. It comes in a number of over the counter (OTC) presentations/formulations to offer consumer choice of flavours and dosing formats. Gaviscon© tablets are currently not considered pleasant to take by some antacid users and thereby have contributed to a lack in volume growth of the Gaviscon© tablet range. To address this issue, RB has conducted qualitative market research to define the ideal tablet. Based on the feedback from consumers, RB has developed a new tablet to improve the organoleptic experience such that the tablet has an improved mouthfeel but still has the same active ingredients at the same doses as the current Gaviscon© tablets. To support the efficacy of the new Gaviscon© product, Reckitt Benckiser wishes to pilot a new technique designed to generate data on speed and duration of action?? of the product. The results of this study will allow further efficacy studies to be designed which can provide data that will form part of the Summary of Product Characteristics (SmPC) for Gaviscon© Chewable tablets.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/27

• Date of REC Opinion

  14 Jun 2010

• REC opinion

  Favourable Opinion