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This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Buckley, Dr | Mercy University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy University Hospital | Cork | County Cork | T12WE28 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12187285 | Background | 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. | |
| 7366233 | 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. |
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IPD will be shared as per local regulations
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 2, 2024 | |
| Reset | Oct 10, 2024 | |
| Release | Feb 3, 2025 | |
| Reset | Feb 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2024 | Oct 10, 2024 | |||
| Feb 3, 2025 |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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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.
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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.
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| 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. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 10218743 | 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. |
| Feb 20, 2025 |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |