Reckitt Benckiser Healthcare (UK) Limited
This investigation is designed to evaluate the acid neutralisation action of a new test product versus unmatched placebo.
Esophagitis
Gastro Oesophageal Reflux Disease
Calcite chewing gum
Unmatched Placebo chewing gum
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 27 participants |
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. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 1, 2022 |
Estimated Primary Completion Date : | May 22, 2023 |
Estimated Study Completion Date : | May 22, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Calcite chewing gum 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 |
Placebo Comparator: Unmatched Placebo chewing gum 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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Mercy University Hospital
Cork, County Cork, Ireland, T12WE28