A randomised, open label, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, using a custom-designed intragastric and oesophageal pH catheter

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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): >= 18.5 and <= 24.9

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 4 weeks prior to screening.
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. Enrolment is defined as the date of informed consent signature.
8) Are taking any of the following medications: antihistamines, tetracyclines, 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 consumption, 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 of 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) Any clinically significant abnormal laboratory result, in the opinion of the Principal Investigator.
20) 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).
21) Pregnancy or lactating mother.
22) Are unable to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator.
23) Those previously randomised i

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the mean percentage of time that pH >= 4 over 0-30<br /><br>minutes post-dose across electrodes 3 to 10. The primary analysis will be the<br /><br>comparison of this endpoint between Sodium alginate oral suspension versus<br /><br>placebo liquid.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The mean percentage of time that pH >= 4 over the interval 30-60 minutes<br /><br>post-dose across electrodes 3 to 10.<br /><br>• The mean percentage of time that pH >= 3 over the intervals 0-30 minutes and<br /><br>30-60 minutes post-dose across electrodes 3 to 10.<br /><br>• The mean percentage of time that pH >= 3 and pH >= 4 over the 10 minute<br /><br>intervals post-dose across electrodes 3 to 10.<br /><br>• The percentage of time that pH >= 3 and pH >= 4 over the 10 minute and 30<br /><br>minute intervals at each electrode.<br /><br><br /><br>These endpoints will be compared between Sodium alginate oral suspension and<br /><br>placebo. For calcium carbonate / magnesium carbonate chewable tablets, these<br /><br>endpoints will be assessed non-comparatively.<br /><br><br /><br>For all treatments, the following will be displayed non-comparatively:<br /><br>• The pH level at each 4 second time point during each monitoring period at<br /><br>each electrode.</p><br>