GORD gastric acid reflux Healthy volunteers heartburn
Conditions
Interventions
Subjects will attend the Clinical Unit on 4 occasions over approximately 7
weeks (one pre-study screening visit [within 21 days prior to the first
treatment visit], two treatment visits [each includ
Sponsors
Reckitt Benckiser Healthcare (Ltd) UK
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the mean percentage of time that pH * 4 over 0-30 minutes post-dose across electrodes 5 to 10. The primary analysis will be the comparison of this endpoint between Gaviscon Double Action Tablets and placebo tablets. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: * The mean percentage of time that pH * 4 over the interval 30-60 minutes post-dose across electrodes 5 to 10. * The mean percentage of time that pH * 3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 5 to 10. * The mean percentage of time that pH * 3 and pH * 4 over the 10 minute intervals post-dose across electrodes 5 to 10. * The percentage of time that pH * 3 and pH * 4 over the 10 minute and 30 minute intervals at each electrode. These endpoints will be compared between Gaviscon Double Action Tablets and placebo. For both treatments, the following will be displayed non-comparatively: * The pH value measured every 4 seconds during each monitoring period at each electrode. | — |
Countries
Netherlands
Outcome results
None listed