Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05129670
Other study ID # 5032701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date May 22, 2023

Study information

Verified date October 2022
Source Reckitt Benckiser Healthcare (UK) Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date May 22, 2023
Est. primary completion date May 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. 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. 2. 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: 1. 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. 2. Patients experiencing frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of severe intensity 3. Patients who are unwilling to refrain from using antacids or alginates 24 hours prior to the start of the treatment visit. 4. 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Ireland Mercy University Hospital Cork County Cork

Sponsors (1)

Lead Sponsor Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00272818 - Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
Recruiting NCT05326113 - The Effect of Physiotherapy on Post POEM Reflux N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Terminated NCT02575391 - The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer Phase 1/Phase 2
Completed NCT00123630 - A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab Phase 2
Completed NCT00256529 - Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia N/A
Completed NCT00081315 - Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer Phase 2
Completed NCT00471094 - Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis Phase 2
Completed NCT00579410 - Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule N/A
Recruiting NCT05109819 - Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression. N/A
Withdrawn NCT01824199 - CYP2C19 Genotype Predictor of Gastric Acid Suppression Early Phase 1
Completed NCT01556919 - Esophageal Monitoring Device for Assessing Mucosal Impedance
Active, not recruiting NCT03835663 - The Bacterial Composition of the Stomach in Reflux Disease
Completed NCT00195208 - Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis Phase 3
Completed NCT00175045 - Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis Phase 2
Recruiting NCT05004155 - Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population
Completed NCT03228147 - Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment N/A
Completed NCT00133770 - Intravenous (IV) Pantoprazole in Erosive Esophagitis Phase 4
Completed NCT01322633 - Risk of Cancer Among Pantoprazole Users N/A