A single-centre, randomised, double-blind, two-way crossover, placebo-controlled pilot study, investigating the use of a novel intragastric and oesophageal pH catheter to characterise the antacid activity of Gaviscon Double Action Liquid in the fasted state followed by a preliminary investigation of the effects of food. - Pilot Gaviscon Double Action pH monitoring study

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: 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.
Sponsor: Reckitt Benckiser Healthcare (UK) Ltd
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

December 23, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 \<6 per day and are willing to abstain from smoking while at the study centre
•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 14

•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.