Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum

Study Overview
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Brief Summary
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This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.

Detailed Description
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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.

Official Title
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Placebo Controlled, Confirmatory Clinical Investigation in Patients With Gastro-oesophageal Reflux, to Characterise the Acid Neutralisation Activity of a Calcite Chewing Gum, Using Oesophageal Ambulatory pH Monitoring

Conditions
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Esophagitis, Gastro Oesophageal Reflux Disease

Intervention / Treatment
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* Device: Calcite chewing gum
* Device: Unmatched Placebo chewing gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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: 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. Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcite chewing gum<br>Patients with a stable pH recording after fasting for at least 6 hours will receive a refluxogenic test meal which will be consumed within 30 mins. Thirty minutes after finishing the meal, the patient will be dosed with the randomised calcite chewing gum. pH and impedance measurements will be collected throughout the treatment period from the baseline assessment to 2 hours post dose | Device: Calcite chewing gum<br>* The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.<br>|
| Placebo Comparator: Unmatched Placebo chewing gum<br>Patients with a stable pH recording after fasting for at least 6 hours will receive a refluxogenic test meal which will be consumed within 30 mins. Thirty minutes after finishing the meal, the patient will be dosed with the randomised unmatched placebo gum product. pH and impedance measurements will be collected throughout the treatment period from the baseline assessment to 2 hours post dose | Device: Unmatched Placebo chewing gum<br>* The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 0 to 1 hour post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time (mins) to first non-acidic reflux event (pH greater or equal to 4 throughout event) | 0 to 2 hours post dose | 
| 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 | The number of acid reflux events (pH is below pH 4) for up to 2 hours post dose | 0 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 | The total number of reflux events for up to 2 hours post dose | 0 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 | 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. | 1 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 0-2 hour 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. | 0 to 2 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastro-oesophageal reflux disease