Intragastric pH change following single dose of Gaviscon/placebo

• Research type

  Research Study

• Full title

  A single-centre, randomised, open-label, two-way crossover, placebo-controlled pilot study, investigating the use of continuous intragastric monitoring of pH change in healthy fasted subjects, following administration of single doses of Gaviscon Double Action Mint liquid compared with a placebo.

• IRAS ID

  47592

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Reckitt Benckiser

• Eudract number

  2010-019176-80

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to monitor the intragastric pH changes following administration of a single dose of Gaviscon Double Action Mint liquid in healthy volunteers. In addition, the method used to measure the pH in the stomach will also be examined. This study has been designed and sponsored by Reckitt Benckiser (RB) and will be conducted by Richmond Pharmacology Ltd (RPL). This study will involve up to 12 healthy volunteers aged 18 to 40 years. Gaviscon Double Action Mint is a medicine that is already available to buy in pharmacies. It is a liquid that works by neutralising the excess stomach acid consequently relieving pain and discomfort. It also provides a protective barrier preventing the flu of stomach acid thus preventing the symptoms of heartburn. This study will be conducted at one site in the UK. Volunteers will be given the medication on two occasions, either Gaviscon or placebo (dummy drug) on the first occasion (Day 1) and the other remaining medication on the second occasion (Day 7). Prior to Day 1, volunteers will be required to attend RPL's unit for a screening visit to assess eligibility for the study, and the day before the first dosing visit (Day 1) to insert the nasogatric tube in order to locate the sphincter (muscle between the oesophagus and stomach). The two dosing days (Days 1 and 7) are outpatient visits and subjects will be admitted to the unit on Day -1 and Day 6. After the second dosing, volunteers will be required to return to the unit on a specified day, 3-7 days after the second dosing visit, for a final follow-up. Each volunteer will therefore participate for approximately 5 weeks in total.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/8

• Date of REC Opinion

  1 Jun 2010

• REC opinion

  Favourable Opinion