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

Not Applicable

Completed

• Conditions: Esophagitis; Gastro Oesophageal Reflux Disease
• Interventions: Device: Calcite chewing gum; Device: Unmatched Placebo chewing gum

• Registration Number: NCT05129670
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

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.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Study Start: 2022-06-01
• Status Verified: 2022-10
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-22
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcite chewing gum	Calcite chewing gum	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
Unmatched Placebo chewing gum	Unmatched Placebo chewing gum	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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.

Trial Locations

Locations (1)

Mercy University Hospital; 🇮🇪 Cork, County Cork, Ireland