Loading clinical trials...

COMPLETEDNA

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

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

NCT05129670•Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

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.

Locations (1)

Mercy University Hospital

Cork, County Cork, Ireland

Key Dates

Start Date

June 1, 2022

Primary Completion Date

May 22, 2023

Completion Date

May 22, 2023

Last Updated

June 8, 2023

Enrollment

ACTUAL participants

Conditions

EsophagitisGastro Oesophageal Reflux Disease

Interventions

Calcite chewing gum

DEVICE

Unmatched Placebo chewing gum

DEVICE

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Prospective Registry of EoSinophilic esOphagitis

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy