Study to investigate the effect of Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid Vs no treatment on the acid pocket.

Conditions: A single-centre, randomised, four-way crossover study to investigate the measurement of the acid pocket and subsequent gastro-oesophageal reflux episodes using a novel pH/impedance catheter in subjects receiving Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid versus no treatment.
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2012-000678-44-GB

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Only subjects to whom all of the following conditions apply will be included:
1)Male or female subjects aged = 18 years, = 50 years

2)Subjects who have used over the counter medication to treat for heartburn, typically at least twice per month for the previous 3 months

3)Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre

4)Willingness to consume the refluxogenic meal

5)Otherwise healthy subjects, in the opinion of the Investigator

6)Those who are willing to volunteer and have provided written informed consent

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 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Only subjects to whom all of the following conditions apply will be included:
1)Male or female subjects aged = 18 years, = 50 years

2)Subjects who have used over the counter medication to treat for heartburn, typically at least twice per month for the previous 3 months

3)Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre

4)Willingness to consume the refluxogenic meal

5)Otherwise healthy subjects, in the opinion of the Investigator

6)Those who are willing to volunteer and have provided written informed consent

Exclusion Criteria

Subjects to whom any of the following conditions apply must be excluded:
1)Those with a history of gastro-oesophageal reflux disease, or reflux symptoms typically requiring self medication with over the counter or prescription medication more than twice a week on an ongoing basis.

2)Those who have a history of active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.

3)Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.

4)Those who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.

5)Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery.

6)Those who have been hospitalised within the previous three months for major surgery or medical illness.

7)Those who have had a clinically significant illness within the previous four weeks.

8)Those who have taken any prescription medication or non-prescription medication (other than hormonal contraceptives) within seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.

9)Those who have taken H2 antagonists or motility stimulants in the two weeks prior to enrolment in the study and during the study.

10)Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study.

11)Any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents.

12)Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents.

13)Those who consume abnormal quantities of coffee, tea or cola (e.g. more than six cups) according to the Principal Investigator’s judgement.

14)Those who have taken part in any clinical study within the previous three months, or have taken part in a total of four or more studies in the last 12 months.

15)Those who 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.

16)Those who have evidence of columnar lined oesophagus, or any other significant abnormality in the opinion of the endoscopist and Investigator (as determined during the endoscopy procedure to place the catheter).

17)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions. Adequate contraceptive precautions include oral or injectable contraceptives, approved hormonal implants or topical patches, intrauterine devices; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. Should the subject become sexually active while participating in the study, she and her partner must agree to use a double barrier method or condoms/diaphragms with spermicidal foam/gel/film/cream/ suppository). Subjects are to be informed verbally that a female condom and male condom should not be used;
Subjects to whom any of the following conditions apply must be excluded:
1)Those with a history of gastro-oesophageal reflux disease, or reflux symptoms typically requiring self medication with over the counter or prescription medication more than twice a week on an ongoing basis.