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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-05-22

Brief Summary

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

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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.

Conditions

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Esophagitis Gastro Oesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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

Group Type EXPERIMENTAL

Calcite chewing gum

Intervention Type DEVICE

The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.

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

Group Type PLACEBO_COMPARATOR

Unmatched Placebo chewing gum

Intervention Type DEVICE

The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.

Interventions

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Calcite 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.

Intervention Type DEVICE

Unmatched 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes