Gaviscon Advance® versus milk of magnesia pH-impedance study

ISRCTN	ISRCTN72875772
DOI	https://doi.org/10.1186/ISRCTN72875772
Protocol serial number	09/H0802/112
Sponsor	Guy's and St Thomas' NHS Foundation Trust (UK)
Funders	Guy's and St Thomas' Hospital NHS Trust (UK) - covering the costs of the procedure and indemnity, Reckitt Benckiser (UK) - covering the cost of Gaviscon Advance® product, Guys' and St Thomas' Charity HPB Fund 872 (UK) - covered additional costs of running the trial and Milk of Magnesia product

Submission date: 18/02/2010
Registration date: 09/06/2010
Last edited: 27/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Terry Wong
Scientific

Oesophageal Laboratory
Department of Gastroenterology
St. Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled double-blind cross-over trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An assessment of combined pH-impedance monitoring for clinical studies of 'Gaviscon Advance®' in gastro-oesophageal reflux disease
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 The study terminates when the catheter is withdrawn.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 / device / biological / vaccine name(s)	Gaviscon Advance®, milk of magnesia
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	01/06/2010
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oesophageal Laboratory

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes