E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Investigating efficacy in terms of heatburn relief in healthy subjects following a refluxogenic meal. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to assess the method used to measure efficacy in terms of relief from heartburn with a new Gaviscon® formulation.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to determine the onset of relief, duration of action, and overall assessment of the study medication compared to a Placebo and Losec®.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the area under the Heartburn Relief curve from 0 to 60 minutes post dose, computed using the trapezoid method (AUCPR0 60). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
A single centre, randomised, partially-blind, placebo-controlled 3 way crossover pilot study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Provided in the protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |