Two forms of Gaviscon, Raft formation, scintigraphy, matched placebos

• Research type

  Research Study

• Full title

  A randomised single dose two cohort study comparing the speed of raft formation assessed by gamma scintigraphy in healthy volunteers following administration of a single dose of Gaviscon® Strawberry Flavour Tablets (2x250mg) or Gaviscon® Original Aniseed Relief (10ml) versus matched placebos.

• IRAS ID

  82125

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2011-002341-35

• ISRCTN Number

  1

• Research summary

  Reckitt Benckiser Healthcare (UK) Ltd is interested tofurther understandraftformation by Gaviscon© products.Alginate raft formation and retention will be assessed using a gamma scintigraphy technique, in a randomised, open label clinical study. Previous studies performed by Reckitt Benckiser have successfully used a gamma scintigraphic method to demonstrate raft formation/retention for a range of liquid alginate products. Similarly, studies have also been successfully performed on tablet alginate formulations using gamma scintigraphy. Healthy volunteers willbe provided with a standard radiolabelled mealwith subsequent administration of a radiolabelled dose of the test product.

• REC name

  Wales REC 1

• REC reference

  11/WA/0164

• Date of REC Opinion

  13 Jul 2011

• REC opinion

  Favourable Opinion