E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastro-oesophageal reflux disease (GORD) |
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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 |
This project will provide extensive mechanistic (i.e. effect of product on underlying pathophysiological mechanism of disease / suppression of acid reflux events) and pilot clinical data (i.e. effect of product on patient symptoms) for the use of Gaviscon Double Action Peppermint liquid in patients presenting with predominantly typical reflux symptoms (heartburn, acid regurgitation) to a single, referral centre for oesophageal measurement serving a multi-ethnic community of 6 million in South-East England.
The primary objective of this study is to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid reflux events in patients with typical reflux symptoms.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid and weakly acid reflux events, oesophageal acid exposure, pepsin in expectorated saliva and clinical benefit in terms of patient reports of reflux symptoms in patients with typical reflux symptoms. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age: ≥ 18 years ≤ 70 years 2. Sex: male and female patients were eligible for entry. 3. Primary diagnosis: those with self-rated at least moderate heartburn or acid regurgitation within 60 minutes following ingestion of a refluxogenic meal on at least 3 occasions a week at the screening visit. 4. Agreement to withhold acid suppressant PPI and H2receptor blocking medications and other medications that affect gastro-intestinal function for 6 days and 3 days respectively prior to the test and during 4 days of monitoring. 5. Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the test and during 4 days of monitoring. 6. Patients who gave written informed consent
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E.4 | Principal exclusion criteria |
1. Those with prominent gastrointestinal symptoms or disease other than reflux (including atypical symptoms e.g. cough, sore throat, belching, nausea) 2. Those with difficulty swallowing (dysphagia), gastrointestinal bleeding, weight loss (>5% body weight) or other alarm symptoms suggestive of neoplastic or severe inflammatory disease within the last 12 months 3. Those with a history or symptoms suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett’s oesophagus or systemic sclerosis. 4. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection 5. Those with known hypophosphataemia or phenylketonuria. 6. Those with severe constipation or history of colonic stenosis. 7. Those with major oesophageal dysmotility on manometry, e.g. achalasia 8. Those with severe reflux oesophagitis on endoscopy (LA grade III-IV) or Barrett Oesophagus on endoscopy. 9. Those with significant co-morbidity requiring ongoing treatment or investigation 10. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants 11. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility) 12. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. sexual 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]. A woman of childbearing potential is defined as any female who has not undergone the menopause or has not had an hysterectomy or surgical sterilisation procedure, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). 13. Those that do not withhold acid suppressant PPI and H2 receptor blocking medications for 6 days and 3 days respectively prior to the test and during 4 days of monitoring. 14. Those that do not withhold antacid or alginate medications for 1 days prior to the test and during 4 days of monitoring (5 days in total) 15. Those who have any previous history of allergy or known intolerance to any of the study drugs or following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate, calcium carbonate, carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, peppermint flavour, sodium hydroxide, Placebo: hydrogenated glucose syrup, peppermint flavour, potassium sorbate, methyl paraben, xanthan gum r80, propyl paraben, citric acid. 16. Failure to accept or to comply with standard requirements for activity and diet during pH testing as set out in appendix II 17. 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 outcome of this study is to compare the effectiveness of Gaviscon Double Action or a closely matched placebo on suppression of acid reflux events in patients with typical reflux symptoms. The primary measure is the number of acid reflux events during 48hr Gaviscon Double Action or matched placebo study period compared to the 48hr “no treatment” study period. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Last subject undergoing trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |