Symptoms of heartburn
Conditions
Interventions
Trade Name: Gaviscon Oral Suspension in Sachets
Product Name: Gaviscon Oral Suspension in Sachets
Pharmaceutical Form: Oral suspension
CAS Number: 9005-38-31
Other descriptive name: SODIUM ALGINATE
Co
Sponsors
Reckitt Benckiser Healthcare UK) Limited
Reckitt Benckiser Healthcare (UK) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: = 18 years = 80 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 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Those who have suffered a recent, significant unexplained weight loss of 6-7kg in the last 6 months. 2) Those who have recently experienced any gastrointestinal bleeding in 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. 8) Those who have taken proton pump inhibitors within the previous 48 hours prior to screening. 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 or potassium bicarbonate. 11) Those who are receiving treatment for their gastrointestinal problems or gastro-oesphageal reflux disease from their GP. 12) Those unable in the opinion of the Investigator to comply fully with the study requirements. 13) Those currently participating in a clinical study or who have participated in any other clinical study within the last 30 days. 14) Those who have previously participated in this randomised study. 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 who are on steroids or non-steroidal anti-inflammatory drugs. 17) Those who are diabetics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to pilot the stopwatch technique for determining the onset of action of products that provide a perceived soothing effect in the throat/oesphagus during heartburn. ;Secondary Objective: The secondary objectives of this study are to evaluate the time to first perceived cooling effect in the throat/oesphagus; the description of an “instant” benefit from the product; the ability of the product to make the mouth/throat feel fresher; and the subject’s willingness to use the product again.;Primary end point(s): The primary efficacy endpoint is the time to first perceived soothing effect using a stopwatch. | — |
Countries
United Kingdom
Outcome results
None listed