Back to resultsClinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum
Primary Purpose
Esophagitis, Gastro Oesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Calcite chewing gum
Unmatched Placebo chewing gum
Sponsored by
About this trial
This is an interventional treatment trial for Esophagitis focused on measuring Gastro-oesophageal reflux disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Mercy University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Calcite chewing gum
Unmatched Placebo chewing gum
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
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
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.
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.
Full Information
NCT ID
NCT05129670
First Posted
October 26, 2021
Last Updated
June 7, 2023
Sponsor
Reckitt Benckiser Healthcare (UK) Limited
1. Study Identification
Unique Protocol Identification Number
NCT05129670
Brief Title
Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Healthcare (UK) Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Gastro Oesophageal Reflux Disease
Keywords
Gastro-oesophageal reflux disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcite chewing gum
Arm Type
Experimental
Arm 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
Arm Title
Unmatched Placebo chewing gum
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Calcite chewing gum
Intervention Description
The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.
Intervention Type
Device
Intervention Name(s)
Unmatched Placebo chewing gum
Intervention Description
The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
0 to 1 hour post dose
Secondary Outcome Measure Information:
Title
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
Description
Time (mins) to first non-acidic reflux event (pH greater or equal to 4 throughout event)
Time Frame
0 to 2 hours post dose
Title
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
Description
The number of acid reflux events (pH is below pH 4) for up to 2 hours post dose
Time Frame
0 to 2 hours post dose
Title
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
Description
The total number of reflux events for up to 2 hours post dose
Time Frame
0 to 2 hours post dose
Title
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
Description
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.
Time Frame
1 to 2 hours post dose
Title
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
Description
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.
Time Frame
0 to 2 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Buckley, Dr
Organizational Affiliation
Mercy University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy University Hospital
City
Cork
State/Province
County Cork
ZIP/Postal Code
T12WE28
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared as per local regulations
Citations:
PubMed Identifier
12187285
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.
Results Reference
background
PubMed Identifier
7366233
Citation
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.
Results Reference
background
PubMed Identifier
10218743
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.
Results Reference
background
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Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum
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