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

Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129670
• Other study ID #: 5032701
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: October 2022
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastro Oesophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Mercy University Hospital	Cork	County Cork

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

DeMeester TR, Wang CI, Wernly JA, Pellegrini CA, Little AG, Klementschitsch P, Bermudez G, Johnson LF, Skinner DB. Technique, indications, and clinical use of 24 hour esophageal pH monitoring. J Thorac Cardiovasc Surg. 1980 May;79(5):656-70. — View Citation

Hunt RH. Importance of pH control in the management of GERD. Arch Intern Med. 1999 Apr 12;159(7):649-57. doi: 10.1001/archinte.159.7.649. — View Citation

Vandenplas Y, Hassall E. Mechanisms of gastroesophageal reflux and gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2002 Aug;35(2):119-36. doi: 10.1097/00005176-200208000-00005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0 to 1 hour post dose
Secondary	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	Time (mins) to first non-acidic reflux event (pH greater or equal to 4 throughout event)	0 to 2 hours post dose
Secondary	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	The number of acid reflux events (pH is below pH 4) for up to 2 hours post dose	0 to 2 hours post dose
Secondary	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	The total number of reflux events for up to 2 hours post dose	0 to 2 hours post dose
Secondary	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	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.	1 to 2 hours post dose
Secondary	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	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.	0 to 2 hours post dose