A randomised, single dose, crossover, open label, placebo controlled confirmatory study with interim analysis in healthy volunteers to characterise the acid neutralisation activity of Gaviscon Double Action Tablets in the fasted state, using an intragastric and oesophageal pH catheter

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

Only subjects to whom all of the following conditions apply will be included:
1. Male or female subjects who have given written informed consent.
2. Age: * 18 years * 50 years.
3. Body Mass Index (BMI): * 18.5 and * 24.9 kg/m2.
4. Height * 1.90 metres
5. Healthy as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.

Exclusion Criteria

Subjects to whom any of the following conditions apply must be excluded:
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 diseases of any body system.
3. A medical history that is associated with an increased risk in study procedures (e.g. basal skull fracture or those who have undergone trans-sphenoidal surgery).
4. Hospitalisation within the previous 3 months for major surgery or medical illness.
5. A clinically significant illness within the 4 weeks prior to screening.
6. Ingestion of any prescription medication or non-prescription medication within the 7 days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
7. Ingestion of 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 the screening visit and during the study and/or have taken proton pump inhibitors in the 4 weeks prior to the screening visit and during the study.
8. Those who are currently taking any of the following medications: antihistamines, tetracyclines, digoxin, quinolones including fluoroquinolone, iron salts, neuroleptics, thyroxine and levothyroxine, penicillamine, beta-blockers (e.g. atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, biphosphonates, ketoconazole, eltrombopag and thiazide diuretics.
9. A history of drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study.
10. A history of allergy or intolerance to the Investigational Medicinal Products (IMP) or the following formulation constituents: e.g. macrogol 20,000, mannitol (E421], copovidone, acesulfame K, aspartame (E951), mint flavour, carmoisine lake (E122), magnesium stearate, xylitol DC (contains carmellose sodium).
11. A current or recent history (within 1 year of the screening visit) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents.
12. Those with a positive screen/test for drugs of abuse and/or alcohol.
13. Those who 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).
14. Those who have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit and from the screening visit up to 48 hours before admission to the Clinical Unit for Treatment Period 1.
15. Those who have consumed alcohol within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
16. Those who regularly consume excessive quantities of caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator*s judgement.
17. Those who have consumed caffeine-containing food and drinks within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
18. Those who are either unable to refrain from using tobacco/nicotine during the study treatment periods or unable to smoke less than 6 cigarettes (or equivalent) per

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 5 to 10. The primary analysis will be the<br /><br>comparison of this endpoint between Gaviscon Double Action Tablets and placebo<br /><br>tablets.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>* The mean percentage of time that pH * 4 over the interval 30-60 minutes<br /><br>post-dose across electrodes 5 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 5 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 5 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>These endpoints will be compared between Gaviscon Double Action Tablets and<br /><br>placebo.<br /><br>For both treatments, the following will be displayed non-comparatively:<br /><br>* The pH value measured every 4 seconds during each monitoring period at each<br /><br>electrode.</p><br>