NCT05129670

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Esophagitis
• Gastro Oesophageal Reflux Disease

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2021-11-22
• Last updated: 2023-06-08

Locations

1 site across 1 country: Ireland