Condition category
Digestive System
Date applied
18/02/2010
Date assigned
09/06/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Terry Wong

ORCID ID

Contact details

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

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 The study terminates when the catheter is withdrawn.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

http://www.guysandstthomas.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes