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NCT05129670 | Completed | Esophagitis


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

Reckitt Benckiser Healthcare (UK) Limited

Brief Summary:

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

Condition or disease

Esophagitis

Gastro Oesophageal Reflux Disease

Intervention/treatment

Calcite chewing gum

Unmatched Placebo chewing gum

Phase

Not Applicable

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.

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
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.

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

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

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Ireland, County Cork

Mercy University Hospital

Cork, County Cork, Ireland, T12WE28

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