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

NCT05129670 | Completed

• 1 other identifier: 5032701
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophagitis; Gastro Oesophageal Reflux Disease

Keywords

Gastro-oesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  0 to 2 hours post dose

• 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

  0 to 2 hours post dose

• 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

  0 to 2 hours post dose

• 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

  1 to 2 hours post dose

• 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

  0 to 2 hours post dose

Study Arms (2)

Calcite chewing gum

EXPERIMENTAL

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

Device: Calcite chewing gum

Unmatched Placebo chewing gum

PLACEBO COMPARATOR

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

Device: Unmatched Placebo chewing gum

Interventions

Calcite chewing gum 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.

Calcite chewing gum

Unmatched Placebo chewing gum 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.

Unmatched Placebo chewing gum

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patient that are healthy (with the exception of a diagnosis of GORD) as determined by past medical history and vital signs at screening.

You may not qualify if:

• 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.
• Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity
• Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit.
• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

Mercy University Hospital

Cork, County Cork, T12WE28, Ireland

Location

Related Publications (3)

• 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.

  PMID: 12187285 BACKGROUND

• 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.

  PMID: 7366233 BACKGROUND

• 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.

  PMID: 10218743 BACKGROUND

MeSH Terms

Conditions

Esophagitis; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Martin Buckley, Dr

  Mercy University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 22, 2021
• Study Start: June 1, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: June 8, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)