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

NCT05129670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-06-08

No results posted yet for this study

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

Interventions

DEVICE

Calcite chewing gum

The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.

DEVICE

Unmatched Placebo chewing gum

The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.

Sponsors & Collaborators

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Martin Buckley, Dr · Mercy University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-05-22
Completion
2023-05-22

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129670 on ClinicalTrials.gov