To pilot the use of a novel pH catheter for the measurement of oesophageal and intragastric pH comparing the onset and duration of antacid action of Gaviscon Double Action versus placebo.
Conditions
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects to whom all of the following conditions apply will be included: 1) Those who are willing to volunteer and have provided written informed consent 2) Age: = 18 years, = 50 years 3) Sex: male or female subjects 4) Status: healthy subjects 5) Those whose cigarette consumption is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects to whom any of the following conditions apply must be excluded: 1) Those who have a history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year. 2) Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease. 3) Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery. 4) Those who have been hospitalised within the previous three months for major surgery or medical illness. 5) Those who have had a clinically significant illness within the previous four weeks. 6) Those who 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) Those who have taken antacids, H2 antagonists, motility stimulants or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study 8) Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study. 9) Those who have a drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study. 10) Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents 11) Those who consume abnormal quantities of coffee, tea or cola (e.g. more than three cups) according to the Principal Investigator’s judgement or consume alcohol regularly. 12) Those who have taken part in any clinical study within the previous four months, or have taken part in a total of four or more studies in the last 12 months. 13) Those who are unable to communicate well with the Chief Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Chief Investigator 14) Those who have evidence of columnar lined oesophagus (as determined during the endoscopy procedure to place the catheter). 15) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). 16) Those previously randomised into this study. 17) Those unable in the opinion of the investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to pilot the use of a novel pH catheter for the measurement of oesophageal and intragastric pH comparing the onset and duration of antacid action of Gaviscon Double Action versus placebo. This study has been designed to develop appropriate endpoints for future studies. ;Secondary Objective: ;Primary end point(s): The primary endpoint will be the assessment of electrode 6 at 1 minute intervals post dose. The primary analyses will be a comparison of the pH values for Gaviscon Double Action versus placebo from the smoothed pH curve at electrode 6 at each 1 minute interval up to four hours post-dose during the fasted state. If the 4 second intervals at which the pH is captured do not match with the end of a 1 minute interval since dosing, linear interpolation will be used between values either side of the smoothed pH curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Comparison of the pH values for Gaviscon Double Action versus placebo from the smoothed pH curve at all other electrodes at each 1 minute interval up to four hours post-dose during the fasted state. If the 4 second intervals at which the pH is captured do not match with the end of a 1 minute interval since dosing, linear interpolation will be used between values either side of the smoothed pH curve. • Time to reach pH 3 on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo • Time to reach pH 4 on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo. • Duration of time at which = pH 3 is maintained on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo. • Duration of time at which = pH 4 is maintained on the smoothed curve at each electrode in the stomach (i.e. electrodes 3-11 inclusive) for Gaviscon Double Action versus placebo. • Change in pH on the smoothed curve at electrode 1 over time for Gaviscon Double Action versus placebo. • Change in pH on the smoothed curve at electrode 2 over time for Gaviscon Double Action versus placebo. As this is a pilot study further exploratory analysis of the data may also occur to develop other relevant endpoints for future studies. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
Reckitt Benckiser Healthcare (UK) Ltd
Outcome results
None listed