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

Reckitt Benckiser

Status: Completed

Conditions: Esophagitis; Gastro Oesophageal Reflux Disease

Treatments: Device: Unmatched Placebo chewing gum; Device: Calcite chewing gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129670

5032701

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups, including a placebo group

Calcite chewing gum

Experimental group

Description:

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

Treatment:

Device: Calcite chewing gum

Unmatched Placebo chewing gum

Placebo Comparator group

Description:

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

Treatment:

Device: Unmatched Placebo chewing gum