A single-centre randomised, partially blind, single dose, crossover study investigating the onset of action of soothing and cooling after taking Gaviscon Peppermint liquid, Double Action Gaviscon liquid, Gaviscon Instants Oral Powder, compared to a control in subjects with heartburn following a refluxogenic meal, using the 2-stopwatch technique - Gaviscon Soothing and Cooling

Active, not recruiting

Conditions: Symptoms of heartburn

Registration Number: EUCTR2008-006413-25-GB

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not 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) Status: Members of the Simbec Volunteer Panel who state (self-rated) that they have a tendency to experience symptoms of heartburn related to 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)
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 with difficulty in swallowing.
4) 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.
5) Those with known hypophosphataemia or phenylketonuria.
6) Those with severe constipation or history of colonic stenosis.
7) Those who have taken any antacids, H2 antagonists, motility stimulants/prokinetics or other medicines for relief of symptoms of acid reflux disease within the previous 24 hours prior to Screening Visit 2.
8) Those who have taken proton pump inhibitors within the previous 48 hours prior to Screening Visit 2.
9) Those with a history of drug, solvent or alcohol abuse.
10) Those with any previous history of allergy or known intolerance to any of the study drugs or following formulation constituents, sodium alginate, calcium carbonate, sodium carbonate, potassium bicarbonate, or hydroxybenzoate (parabens).
11) Those who have a history of cardiovascular disorders or show evidence of clinically significant cardiovascular disease.
12) Those with any previous history of allergy or known intolerance to milk, soya, or wheat.
13) Those who are receiving treatment for their upper gastrointestinal problems or gastro-oesophageal reflux disease from their GP.
14) Those unable in the opinion of the Investigator to comply fully with the study requirements.
15) Those currently participating in a clinical study or who have participated in any other clinical study within the last 30 days.
16) Those who have previously participated in this randomised study.
17) 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).
18) Those who are on steroids or non-steroidal anti-inflammatory drugs.
19) Those who are diabetics.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary efficacy end-points are the times to first perceived soothing and cooling effects in the throat/oesophagus (foodpipe). ;Main Objective: The primary objective is to determine the time to onset of action in terms of providing a perceived soothing effect and a perceived cooling effect in the throat/oesophagus (foodpipe), compared to the control.;Secondary Objective: The secondary objectives are to determine the subject’s willingness to use the product(s) again and replace their current therapy.

Secondary Outcome Measures