This study assesses suppression of gastro-oesophageal reflux of Gaviscon in patients with gastro-oesophageal reflux disease.
Conditions
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age: = 18 years = 70 years. 2.Sex: male and female patients. 3.Patients referred to secondary care for further investigation of typical reflux symptoms (heartburn and/or acid regurgitation). Patients must have been referred to secondary care within 2 years of the start of the study. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least three days a week during the two weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms. Patients must be symptomatic when withholding prescribed medication for reflux disease. *Symptom intensity should be assessed using the following scale; •Mild: awareness of symptom but easily tolerated •Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep •Severe: incapacitating symptom with inability to perform normal activities, including sleep 4.No major esophageal dysmotility (i.e. achalasia, esophageal spasm / hypertensive dysmotility, aperistalsis) or presence of hiatus hernia >3 cm on Oesophageal Manometry or High Resolution Manometry (HiRM) 5.Agreement to withhold acid suppressant PPI and H2 receptor blocking medications and other medications that affect gastro-intestinal function (e.g macrolide antibiotics such as erythromycin and azithromycin, and 5HT agonists such as sumatriptan) for 2 weeks prior to the start of the study and throughout the treatment periods. 6.Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the start of the study and throughout the treatment periods. 7.Patients who give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
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 (>5% body weight) or other 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 Gastrointestinal (GI) surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection. 5.Those with known hypophosphataemia. 6.Those with severe constipation or history of colonic stenosis. 7.Those with major oesophageal dysmotility e.g. achalasia, or with hiatus hernia >3 cm on manometry. 8.Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants (including anti-platelet drugs). 9.Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility). 10.Those on a highly restricted salt diet. 11.Those with, or a history of, hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. 12.Those with clinically abnormal laboratory assessments at screening. Repeat laboratory assessments will not be performed. 13.Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent. 14.Pregnancy or lactating mother. 15.Those who have already participated in the study, including the validation phase. 16.Those who are an employee at the study site. 17.Partner or first-degree relative of the Investigator. 18.Any previous history of allergy or known intolerance to any constituents of the IMP, including: sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer and xanthan gum. 19.Failure to accept or to comply with standard requirements for activity and diet during pH testing as set out in the patient diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effectiveness of Gaviscon Double Action with a matched placebo liquid on the suppression of acid reflux events in patients with reflux symptoms;Secondary Objective: Secondary objectives are to compare the effectiveness of Gaviscon Double Action Mint versus matched placebo liquid on suppression of acidic and weakly acidic events, oesophageal acid exposure, and clinical benefit in terms of patient reports of reflux symptoms in patients with typical reflux symptoms.; Primary end point(s): The primary endpoint is the number of acid reflux events during the first 24 hour period following treatment with Gaviscon Double Action Mint versus matched placebo liquid. An acid reflux event is defined as a fall in pH to less than pH 4 with a duration of at least 12 seconds duration (i.e. three consecutive measurements since the Bravo capsule logs pH data every 6 seconds and signal detection recognition requires two consecutive pH measurements at pH<4 to register an acid reflux event). ;Timepoint(s) of evaluation of this end point: Day 3 and Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The combined number of acid reflux events and weakly acid reflux events during a 24 hour period. A reflux event is defined as a fall in pH which is maintained for a duration of at least 12 seconds, where acidic is defined as pH<4 and weakly acidic as between pH 4 and 5. •The combined number of acid and weakly acidic reflux events in the upright position during a 24 hour period. •The number of acid reflux events in the upright position during a 24 hour period. •The number of weakly acidic reflux events in the upright position during a 24 hour period. •The combined number of acid and weakly acidic reflux events in the supine position during a 24 hour period. •The number of acid reflux events in the supine position during a 24 hour period. •The number of weakly acidic reflux events in the supine position during a 24 hour period. •Oesophageal acid exposure (percentage of time with pH less than pH 4) during a 24 hour period. •Oesophageal weakly acidic exposure (percentage of time with pH less than pH 5) during a 24 hour period. •The number, severity and duration of typical reflux symptoms (heartburn, acid regurgitation) documented by study participants in the patient diary card during a 24 hour period. •The number of typical reflux symptoms (heartburn, acid regurgitation) in the postprandial and night-time periods in the 2hr period after self-administration of the test product. ;Timepoint(s) of evaluation of this end point: As detailed above | — |
Countries
United Kingdom
Outcome results
None listed