Investigation into the Speed of Raft formation in healthy volunteers

• Research type

  Research Study

• Full title

  A randomised, single-dose, double-blind, 2-way crossover, single-centre pilot study to compare the speed of raft formation assessed by gamma scintigraphy in healthy volunteers following administration of Gaviscon® Double Action Tablets and matching placebo tablets.

• IRAS ID

  111466

• Contact name

  SALVATORE FEBBRARO

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2012-004344-29

• ISRCTN Number

  to be registered

• Research summary

  The purpose of the study is to determine how fast a foamy layer (called a ??raft??) is formed in the stomach following a dose of Gaviscon© Double Action Tablets. In order to see how fast the ??raft?? is formed after taking Gavison© Tablets, a technique called Gamma Scintigraphy will be used. Gamma Scintigraphy is a technique used to capture the movement of a radioactive tracer inside the body. The study consists of 1 screening visit, 2 treatment visits and 1 follow-up visit. This study has a randomised and blinded design. It is randomised because each subject will receive Gaviscon© Tablets and Placebo Tablets over the 2 treatment visits in a randomised order.

• REC name

  Wales REC 1

• REC reference

  12/WA/0329

• Date of REC Opinion

  12 Nov 2012

• REC opinion

  Favourable Opinion