Gaviscon, 4-way crossover & refluxogenic meal study

• Research type

  Research Study

• Full title

  A single-centre randomised, partially blind, single dose, crossover study investigating the onset of action of soothing and cooling after taking Gaviscon Peppermint liquid, Double Action Gaviscon liquid, Gaviscon Instants Oral Powder, compared to a control in subjects with heartburn following a refluxogenic meal, using the 2-stopwatch technique.

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2008-006413-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study is being performed to support claims that the test product(s) deliver faster soothing and cooling effects compared to the control. Time to onset of action will be determined using the 2-stopwatch technique. Participants will be selected from a database of volunteers offering their services for clinical research. As this is a healthy volunteer study, there is not expected to be any therapeutic benefit to the volunteer taking part. Volunteers offering their services for healthy volunteer studies have not been consulted in the design and details of the research. Likewise, there will be no formal feedback of the research to study volunteers, unless they ask about the outcome of the trial.THE 4 TREATMENTS ARE:1). Gaviscon Peppermint liquid 2). Gaviscon Double Action Liquid3). Gaviscon Instants Oral Powder4). Control (sublingual tablet, with no active ingredients) Each of the research participants will attend the research unit on 7 occasions i.e. 2 screening visits, 4 study treatment visits and 1 post study follow-up visit.This is a crossover study which means that on each of the 4 study treatment visits each volunteer will be administered a different one of the 4 study treatments (i.e. so that by the end of the 4 treatment visits all of the participants would have been administered each of the study drugs).Eligible subjects will attend the research unit for the second screening visit. On this visit they will be required to eat a fluogenic meal (e.g. a high fat meal) and then asked to confirm that they experience moderate heartburn. If this is experienced then the subjects can proceed to the treatment parts of the study. At the time of dosing 2 stopwatches will be started for each subject. The subject will be instructed to stop one stopwatch when he/she perceives a soothing effect and to stop the other stopwatch when he/she perceives a cooling effect.There will be a minimum of 2 and a maximum of 7 days between each study treatment visit. The total blood volume taken from each participant during the study will be 12 mls from males and 17 mls from females.

• REC name

  Wales REC 1

• REC reference

  08/WSE04/82

• Date of REC Opinion

  9 Dec 2008

• REC opinion

  Favourable Opinion