Gaviscon Advance® versus milk of magnesia pH-impedance study

ISRCTN	ISRCTN72875772
DOI	https://doi.org/10.1186/ISRCTN72875772
Secondary identifying numbers	09/H0802/112

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

Study design	Randomised controlled double-blind cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 The study terminates when the catheter is withdrawn.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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Gaviscon Advance®, milk of magnesia
Primary outcome measure	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 study start date	01/06/2010
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Oesophageal Laboratory

London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

Research & Development Department
3rd Floor Conybeare House
St Thomas Street
London
SE2 9RT
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

Guy's and St Thomas' Hospital NHS Trust (UK) - covering the costs of the procedure and indemnity

No information available

Reckitt Benckiser (UK) - covering the cost of Gaviscon Advance® product

No information available

Guys' and St Thomas' Charity HPB Fund 872 (UK) - covered additional costs of running the trial and Milk of Magnesia product

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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