Gaviscon® Double Action Acid Pocket Investigation

• Research type

  Research Study

• Full title

  A single-centre, randomised, four-way crossover study to investigate the measurement of the acid pocket and subsequent gastro-oesophageal reflux episodes using a novel pH/impedance catheter in subjects receiving Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid versus no treatment.

• IRAS ID

  109062

• Contact name

  Simon L Singer

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd.

• Eudract number

  2012-000678-44

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Following recent discoveries of a highly acidic layer on the top of the stomach contents described as "acid pocket", which has been linked to symptoms of flu disease, Study Sponsor - Reckitt Beckiser, decided to explore the formation of that phenomenon. The formation of the "acid pocket" and associated flu episodes will be assessed following a high fat test meal. This will be assessed in volunteers receiving no treatment or dosed with dosed with Gaviscon© Advance Liquid, Gaviscon© Double Action Liquid or Placebo Liquid. We will be using a double novel probe, which can measure the pH at 11 different levels as well as flu episodes in the oesophagus. A total of 8 subjects will participate in the first part - Validation Phase of the study. In this phase volunteers will be expected to attend the Clinic on 3 occasions including data collection visit which will involve two overnight stays in the Unit. It is also planned that 16 volunteers should complete and have a full set of data for the Clinical Phase of the study, therefore higher numbers might be enrolled and assessed to ensure sufficient number of volunteers complete the study with full data. Volunteers in the Clinical phase will be expected to attend the study site on 4 occasions including two data collection visits, each involving two overnight stays. Participants in the Clinical phase might also receive one of the study treatments or a dummy drug (placebo) or will be left untreated. Male and female volunteers aged 18 to 50 inclusive will participate in either of the study parts. Volunteers who take part in the Validation phase will not be allowed to participate in the Clinical phase. Both study parts will be carried out at ICON Development Solutions Manchester with support from the Endoscopy and Radiology Units at Manchester Royal Infirmary.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  12/EM/0265

• Date of REC Opinion

  4 Sep 2012

• REC opinion

  Further Information Favourable Opinion