Gaviscon chewable tablets & Gaviscon Peppermint scintigraphy study

• Research type

  Research Study

• Full title

  A single-centre randomised, open, two-period crossover study to investigate and compare the formation and retention of alginate rafts assessed by gamma scintigraphy monitoring in healthy volunteers, following administration of single doses of Gaviscon® chewable tablets (2x250mg) and Gaviscon® Peppermint Liquid Relief (10ml).

• IRAS ID

  37636

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2009-017373-38

• ISRCTN Number

  1

• Research summary

  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, Reckitt Benckiser (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 (taste, colour, odour, feel) 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 and liquid. To ensure that the newly formulated Gaviscon© chewable tablets (2x250mg) are equivalent (or non-inferior) to their liquid counterpart, it is necessary to compare alginate raft formation and retention, using a gamma scintigraphy technique, in a randomised, crossover, open-label clinical study. Previous studies performed by Reckitt Benckiser have successfully demonstrated the use of a gamma scintigraphic method in demonstrating raft formation/retention for a range of liquid alginate products1,2,3,4. Similarly, studies have also been successfully performed on tablet alginate formulations using gamma scintigraphy 5,6,7,8,9,10. The therapeutic action of the new chewable tablets will be solely dependent on physicochemical properties for its mode of action like other Gaviscon© formulations. It is anticipated that the new chewable tablet formulation will have non-inferior raft formation and retention properties relative to the Gaviscon© Peppermint Liquid Relief, and will not cause any unwanted side-effects. Healthy volunteers will be used for this study. They will be provided with a standard radiolabelled meal (Technetium-99m radiolabel (99mTc)) with subsequent administration of a radiolabelled dose of the new Gaviscon© chewable tablets (2x250mg) or 10ml liquid orally. The investigational medicinal products (IMPs) will be radiolabelled with Indium-111 (111In).

• REC name

  Wales REC 1

• REC reference

  10/WSE04/15

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion