This study is to demonstrate the antacid action of Gaviscon Double Action Mint versus a matched placebo using a pH catheter.
Conditions
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent has been obtained. 2) Age: = 18 years, = 50 years. 3) Sex: male or female subjects. 4) Status: healthy subjects. 5) Body Mass Index (BMI): between 18.5 and 24.9. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) A history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year. 2) Clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease. 3) A history of basal skull fracture or who have undergone trans-sphenoidal surgery. 4) Have been hospitalised within the previous three months for major surgery or medical illness. 5) A clinically significant illness within the previous 4 weeks. 6) Have taken any prescription medication or non-prescription medication within the last seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study. 7) Have taken antacids, H2 antagonists, motility stimulants (e.g prokinetics, macrolide antibiotics such as erythromycin and azithromycin, and 5HT agonists such as sumatriptan) or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study and/or have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study. 8) Are taking any of the following medications: antihistamines, tetracyclines, antifungals, digoxin, fluoroquinolone, iron salt, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, and biphosphonates. 9) Have a drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study. 10) Any previous history of allergy or known intolerance to any of the Investigational Medicinal Product’s (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer and xanthan gum. 11) Those with known hypophosphataemia. 12) Those on a highly restricted salt diet. 13) Those with, or a history of, hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. 14) A current or recent (within one year) history of alcohol abuse or significant abuse of any legal or illegal drugs, substances and solvents. 15) Regularly (weekly) consume excessive amounts of alcohol (> 8 units for men and > 6 units for women in one sitting, excessive amounts as defined by the UK National Office of Statistics). 16) Have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit. 17) Regular consumption of excessive quantities caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator’s judgement. 18) Tobacco use is > 6 cigarettes per day or equivalent or unable to refrain from tobacco/ nicotine use during the study periods. 19) Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions (as defined in the protocol or are unwilling to be sexually abstinent (as defined in the protocol). 20) Pregnancy or lactating mother. 21) Those who are known to be unable to tolerate insertion of the catheter or endoscope. 22)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the antacid action of Gaviscon Double Action Mint versus matched placebo liquid over 0-30 minutes post dose.;Secondary Objective: The secondary objectives of this study are to demonstrate the duration of separation in terms of antacid action of Gaviscon Double Action Mint versus matched placebo liquid over 1 hour post dose.;Primary end point(s): The primary endpoint will be the mean percentage of time that pH = 4 over 0-30 minutes post-dose across electrodes 6 to 10. The primary analysis will be the comparison of this endpoint between Gaviscon Double Action Mint versus matched placebo liquid.;Timepoint(s) of evaluation of this end point: 30 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The mean percentage of time that pH = 4 over the interval 30-60 minutes post-dose across electrodes 6 to 10. • The mean percentage of time that pH = 3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 6 to 10. • The mean percentage of time that pH = 3 and pH = 4 over the 10 minute intervals post-dose across electrodes 6 to 10. • The percentage of time that pH = 3 and pH = 4 over the 10 minute and 30 minute intervals at each electrode (1-11). • The pH level at each 4 second time point during each monitoring period at each electrode. ;Timepoint(s) of evaluation of this end point: Various, as detailed above in Secondary end points. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
Reckitt Benckiser Healthcare (UK) Ltd
Outcome results
None listed