A single centre, randomised, partially-blind, placebo-controlled 3 way crossover pilot study investigating efficacy in terms of heartburn relief after taking (2x250mg) Gaviscon® chewable tablets, (1x20mg) Losec® MUPS® tablet and (2x) Placebo tablets in subjects with heartburn following a refluxogenic meal. - Three-period crossover pilot study in healthy subjects susceptible to heartburn.

• Conditions: Investigating efficacy in terms of heatburn relief in healthy subjects following a refluxogenic meal.

• Registration Number: EUCTR2010-019414-24-GB
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 19 March 2012

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)Age: = 18 years = 65 years
2)Sex: Male and female subjects are eligible for entry.
3)Subjects who have a tendency to experience symptoms of heartburn (a burning sensation behind the breastbone) of moderate severity associated with reflux, following some meals.
4)Primary diagnosis: Those with self-rated at least moderate heartburn within 60 minutes following ingestion of a standardised refluxogenic meal at the second screening visit.
5)Subjects who have given 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects to whom any of the following conditions apply must be excluded:
1)Those who have suffered a recent, significant unexplained weight loss of 6-7kg in the last 6 months.
2)Those who have experienced any gastrointestinal bleeding within the last 12 months.
3)Those who have taken any antacids, H2-receptor antagonists, motility stimulants/prokinetics or other medicines for relief of symptoms of acid reflux within the previous 2 weeks of screening.
4)Those who have taken proton pump inhibitors within the previous 4 weeks of screening.
5)Those with severe constipation or history of colonic stenosis.
6)Those with known hypophosphataemia or phenylketonuria.
7)Those with a history of drug, solvent or alcohol abuse
8)Those who are receiving treatment for their upper gastrointestinal problems or gastro-oesophageal reflux disease from their GP.
9)Those currently participating in a clinical study or who have participated in any other clinical study within the last 30 days.
10)Those who have previously participated in this randomised study.
11)Those with difficulty in swallowing or chewing (e.g. those who have loose teeth, dentures, fillings, etc).
12)Those who have a history of cardiovascular disorders or show evidence of clinically significant cardiovascular disease.
13)Those who are on steroids or non-steroidal anti-inflammatory drugs.
14)Those who are diabetic.
15)Those with a history and/or symptom profile suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett’s oesophagus or systemic sclerosis.
16)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).
17)Those who are known to be hypersensitive or allergic to any of the active substances (e.g. sodium alginate, sodium bicarbonate, calcium carbonate, Omeprazole), any of the excipients (Gaviscon® Tablets: Poly vinyl pyrrolidone (povidone K30), Acesulfame potassium, Mannitol 100SD, Erythritol, Peppermint Flavour 108406, Colloidal silicon dioxide anhydrous, Polyethylene glycol (Macrogol 20000), Stearic Acid Coarse Powder, Aspartame,
Losec® Tablets: Mannitol, Hyprolose, Cellulose Microcrystalline, Anhydrous Lactose, Sodium lauryl Sulphate, Disodium Hydrogen Phosphate Dihydrate, Hypromellose, Methacrylic Acid Copolymer, Macrogol, Colours E171 and E172, Gelatin and Magnesium Stearate.
Placebo Tablets: Acesulfame K, Mannitol 100SD, Erythritol , Peppermint Flavour 108406, Silica Colloidal anhydrous. Polyethylene glycol 20000, Stearic Acid Coarse Powder, Aspartame
18)Those who are vegetarians
19)Those unable in the opinion of the Investigator to comply fully with the study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified