Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/H0802/112
Study information
Scientific title
An assessment of combined pH-impedance monitoring for clinical studies of 'Gaviscon Advance®' in gastro-oesophageal reflux disease
Acronym
Study hypothesis
The study hypothesis is that Gaviscon Advance®:
1. Will not impair the sensitivity of pH-impedance monitoring in vitro or in vivo
2. Suppresses both non-acid and acid reflux (distal and proximal reflux events) assessed by pH-impedance over a 4-hour period after a standardised test meal and over 24-hour ambulatory monitoring
3. Reduces the presence of pepsin in expectorated saliva 4 hours after a test meal
Ethics approval
Not provided at time of registration
Study design
Randomised controlled double-blind cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oesophageal reflux
Intervention
Gaviscon Advance® or Milk of Magnesia will be provided during 28-hour pH-impedance monitoring. The study takes 28 hours in total; a 4-hour ambulatory pH-impedance study followed by a 4-hour observation after a meal with the catheter in situ. The study terminates when the catheter is withdrawn. There will be no follow-up thereafter.
Intervention type
Drug
Phase
Not Applicable
Drug names
Gaviscon Advance®, milk of magnesia
Primary outcome measures
Gaviscon Advance®:
1. Will not impair the sensitivity of pH-impedance monitoring in vitro or in vivo
2. Will suppress both non-acid and acid reflux (distal and proximal reflux events) assessed by pH-impedance over a 4-hour period after a standardised test meal and over 24-hours ambulatory monitoring
3. Reduces the presence of pepsin in expectorated saliva 4 hours after a test meal
In both in vitro and in vivo studies the effects of 'Gaviscon Advance®' will be compared to another over-the-counter antacid (Milk of Magnesia) that does not exhibit raft-forming properties (a characteristic unique to Gaviscon Advance® in which a roof is formed above gastric contents thereby preventing reflux). This is measured as soon as the catheter is withdrawn and the information on the received is downloaded. It is part of the routine analysis performed by the proprietary software for pH-impedance.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2010
Overall trial end date
01/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 65 years, either sex
2. History of reflux symptoms (heartburn, acid regurgitation, chest pain) requiring referral for oesophageal manometry and pH studies
3. Patients with chronic cough or dental problems are not excluded from the trial; however, typical reflux symptoms must be present also. This is because there is little evidence that reflux events are responsible for symptoms in this group
4. Provision of written, fully informed consent to undergo mechanistic study procedures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Significant gastrointestinal symptoms or disease other than reflux
2. Large hiatus hernia (greater than 3 cm)
3. Severe reflux oesophagitis or Barrett's oesophagus on endoscopy (Los Angeles [LA] classification grade III - IV)
4. Previous upper gastrointestinal (GI) surgery or interventions such as oesophageal dilatations
5. Predominant symptoms of motility disorders, e.g. dysphagia
6. Presence of major oesophageal dysmotility on manometry, e.g. achalasia, diffuse spasm, aperistalsis (greater than 80% swallows)
7. Significant co-morbidity requiring ongoing treatment or investigation
8. Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility)
9. Pregnancy or lactation at the time of enrolment
Recruitment start date
01/06/2010
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oesophageal Laboratory
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Research & Development Department
3rd Floor Conybeare House
St Thomas Street
London
SE2 9RT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St Thomas' Hospital NHS Trust (UK) - covering the costs of the procedure and indemnity
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Reckitt Benckiser (UK) - covering the cost of Gaviscon Advance® product
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Guys' and St Thomas' Charity HPB Fund 872 (UK) - covered additional costs of running the trial and Milk of Magnesia product
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23600790
Publication citations
-
Results
Sweis R, Kaufman E, Anggiansah A, Wong T, Dettmar P, Fried M, Schwizer W, Avvari RK, Pal A, Fox M, Post-prandial reflux suppression by a raft-forming alginate (Gaviscon Advance) compared to a simple antacid documented by magnetic resonance imaging and pH-impedance monitoring: mechanistic assessment in healthy volunteers and randomised, controlled, double-blind study in reflux patients., Aliment. Pharmacol. Ther., 2013, 37, 11, 1093-1102, doi: 10.1111/apt.12318.