Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GA1001
Study information
Scientific title
A randomised, double-blind placebo-controlled study in patients with reflux symptoms to assess suppression of gastro-oesophageal reflux by 'Gaviscon Double Action peppermint liquid' using the BRAVO System
Acronym
Study hypothesis
The primary hypothesis is that in patients presenting with symptoms suggesive of reflux disease, reflux suppression of Gaviscon Double Action (a liquid product containing antacid and alginate components which treats heartburn and indigestion) is effective at reflux suppression and symptom reduction compared to a closely matched placebo or no treatment.
This is a pilot, mechanistic study that is designed primarily to test the mechanism of the effect (i.e. reflux suppression) with clinical efficacy (i.e. symptom suppression) as a secondary outcome
Ethics approval
Not provided at time of registration
Study design
Randomised controlled double-blind parallel-group study
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 to request a patient information sheet
Condition
Gastroesophageal reflux disease
Intervention
A wireless pH monitoring capsule will be attached into the oesophagus endoscopically as per routine. Patients are then sent away with a wireless receiver to collect information regarding oesophageal acid exposure, and a diary card to record all symptoms and events for two consecutive sets of 48 hours. Gaviscon Double Action Peppermint liquid or a closely matched placebo will be self-administered four times a day after meals and before bed for two days and no treatment will be administered on the other two days. The sequence of these periods will follow consecutively and will be determined by prior randomisation. For all subjects, acid reflux events and symptoms will be recorded over all four days, after which the treatment/investigation period for that patient will terminate.
Intervention type
Drug
Phase
Not Applicable
Drug names
Gaviscon Double Action peppermint liquid
Primary outcome measure
The number of acid reflux events during 48 hour Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period
Secondary outcome measures
1. The combined number of acid reflux events and weakly acid reflux events during the Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period. A weakly acid reflux event is defined as any fall in pH of more than 2 pH units in an interval of less than 1 minute which is maintained for a duration of at least 12 seconds.
2. Oesophageal acid exposure (percentage of time with pH less than pH 4) during the Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period
3. Categorical presence/absence of pepsin in expectorated saliva acquired 2 hours after the main evening meal on each test day at detection threshold 16 ng/ml of 'pepsin lateral flow test'
4. Pepsin concentration in expectorated saliva acquired 2 hours after the main evening meal on each test day assessed by ELISA
5. Severity and duration of symptoms/time until symptomatic relief, documented by study subjects in the patient diary
6. The number of typical reflux symptoms (heartburn, acid regurgitation) documented by study participants on data logger/receiver and diary card during the Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period
7. The number of typical reflux symptoms (heartburn, acid regurgitation) in the postprandial and night-time periods in the 2 hour period after self-administration of the test product during the Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period
Overall trial start date
01/12/2010
Overall trial end date
01/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than or equal to 18 years and less than or equal to 70 years
2. Male and female patients
3. Primary diagnosis is those with self-rated at least moderate heartburn or acid regurgitation within 60 minutes following ingestion of a refluxogenic meal on at least three occasions a week at the screening visit
4. Agreement to withhold acid suppressant PPI and H2 receptor blocking medications and other medications that affect gastro-intestinal function for 6 days and 3 days respectively prior to the test and during 4 days of monitoring
5. Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the test and during 4 days of monitoring
6. Patients who gave written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (20 in each arm)
Participant exclusion criteria
1. Those with prominent gastrointestinal symptoms or disease other than reflux (including atypical symptoms, e.g. cough, sore throat, belching, nausea)
2. Those with difficulty swallowing (dysphagia), gastrointestinal bleeding, weight loss (greater than 5% body weight) or other alarm symptoms suggestive of neoplastic or severe inflammatory disease within the last 12 months
3. Those with a history or symptoms suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
4. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection
5. Those with known hypophosphataemia or phenylketonuria
6. Those with severe constipation or history of colonic stenosis
7. Those with major oesophageal dysmotility on manometry, e.g. achalasia
8. Those with severe reflux oesophagitis on endoscopy (LA grade III - IV) or Barrett's oesophagus on endoscopy
9. Those with significant co-morbidity requiring ongoing treatment or investigation
10. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants
11. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility)
12. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. sexual an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method]). A woman of childbearing potential is defined as any female who has not undergone the menopause or has not had an hysterectomy or surgical sterilisation procedure, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
13. Those that do not withhold acid-suppressant PPI and H2 receptor blocking medications for 6 days and 3 days respectively prior to the test and during 4 days of monitoring
14. Those that do not withhold antacid or alginate medications for 1 days prior to the test and during 4 days of monitoring (5 days in total)
15. Those who have any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate, calcium carbonate, carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, peppermint flavour, sodium hydroxide, Placebo: hydrogenated glucose syrup, peppermint flavour, potassium sorbate, methyl paraben, xanthan gum r80, propyl paraben, citric acid
16. Failure to accept or to comply with standard requirements for activity and diet during pH testing
17. Those unable in the opinion of the Investigator to comply fully with the study requirements
Recruitment start date
01/12/2010
Recruitment end date
01/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Reckitt Benckiser Healthcare (UK)
Sponsor details
Dansom Lane
Hull
HU8 7DS
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Reckitt Benckiser Healthcare (UK)
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
Basic results (scientific)
Publication list