Esophagitis, Gastro Oesophageal Reflux Disease
Conditions
Keywords
Gastro-oesophageal reflux disease
Brief summary
This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.
Detailed description
The primary objective of this confirmatory clinical investigation is to evaluate the acid neutralisation action of a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. The clinical investigation will also assess the efficacy and safety of the calcite chewing gum.
Interventions
DEVICECalcite chewing gum
The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.
DEVICEUnmatched Placebo chewing gum
The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients and the staff at the Investigative site, will remain un-masked to treatment administered. Masking of the investigation is not required as the investigation endpoints are objective measurements of oesophageal pH and impedance, patients will be randomised to a treatment order.
Intervention model description
This clinical investigation is being conducted to characterise the acid neutralisation activity of the test product, a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. In this clinical investigation, the test product's ability to increase the pH within the oesophagus will be evaluated against an unmatched placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patient with a primary diagnosis of symptomatic GORD in accordance with the Montreal definition. Patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of mild/moderate intensity. If the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms. 2. Patient that are healthy (with the exception of a diagnosis of GORD) as determined by past medical history and vital signs at screening.
Exclusion criteria
1. Patients with a history or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) or hiatus hernia which is greater than 3 cm or a history of conditions that can lead to abnormal oesophageal pH. 2. Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity 3. Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit. 4. Patients who are unwilling to refrain from using proton pump inhibitors (PPIs), H2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to the start of treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure efficacy of the calcite chewing gum versus unmatched placebo by measurement of the mean percentage of time (%) that the pH of the oesophagus is greater or equal to 4 up to 1 hour post dosing | 0 to 1 hour post dose | The mean percentage of time (%) that pH is greater or equal to 4 within the oesophagus during the 0-1 hour post dose monitoring period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of the test product versus the unmatched placebo by measurement of the time (mins) taken to observe the first non-acidic reflux event (pH greater or equal to 4 throughout event) immediately after the start of dosing | 0 to 2 hours post dose | Time (mins) to first non-acidic reflux event (pH greater or equal to 4 throughout event) |
| To evaluate the efficacy of the test product versus the unmatched placebo by recording the number of acid reflux events (pH is below pH 4) for up to 2 hours post dose | 0 to 2 hours post dose | The number of acid reflux events (pH is below pH 4) for up to 2 hours post dose |
| To evaluate the efficacy of the test product versus the unmatched placebo by recording the total number of reflux events up to 2 hours post dose | 0 to 2 hours post dose | The total number of reflux events for up to 2 hours post dose |
| To evaluate the efficacy of the test product versus the unmatched placebo by recording the mean percentage of time (%) that the pH within the oesophagus is raised greater or equal to 4 over the period 1-2 hour post dose | 1 to 2 hours post dose | The mean percentage of time (%) that pH is greater or equal to 4 within the oesophagus during the 1-2 hour post dose monitoring period. |
| To evaluate the efficacy of the test product versus the unmatched placebo by recording the mean percentage of time (%) that the pH within the oesophagus is raised greater or equal to 4 over the period 0-2 hour post dose | 0 to 2 hours post dose | The mean percentage of time (%) that pH is greater or equal to 4 within the oesophagus during the 0-2 hour post dose monitoring period. |
Countries
Ireland
Outcome results
None listed