Gastro-Oesophageal Reflux Disease (GORD)
Conditions
Interventions
Trade Name: Gaviscon Double Action Tablets
Product Name: Gaviscon Double Action Tablets
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: SODIUM
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent has been freely given. 2. Males and females = 18 years. 3. Primary diagnosis: Current documented evidence of symptomatic GORD in accordance with the Montreal definition. This evidence can be based solely on symptom characteristics. Patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of at least moderate intensity* during the last 3 months and also on at least five days during the week before the start of screening. If the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms. *Symptom intensity should be assessed using the following scale: I. Mild: awareness of symptom but easily tolerated II. Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep III. Severe: incapacitating symptom with inability to perform normal activities, including sleep 4. At Visit 2, all 12 items of the RDQ are to be completed with a minimum score of 1.5 for heartburn recorded. 5. Status: Patients may be referred from either their General Practitioner (GP) / consultant or by attending the investigational site, without GP referral, in response to an advertisement to join this clinical study. In addition patients may be recruited by the clinic from hospital databases or out-patient clinics. 6. Patients must be sufficiently literate to be able to complete the RDQ unaided. 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 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: Patients to whom any of the following conditions apply must be excluded: 1. Those who have a current or recent (within one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances or solvents. 2. Patients with a history and / or symptom profile indicative of severe diseases of major body systems. 3. Patients either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or interfere with assessment of efficacy; or with any clinically significant abnormal laboratory values. 4. Patients presenting with a history of psychiatric diagnosis according to Chapter V International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)-2015-WHO. 5. Presence of clinically significant abnormalities in the physical examination, endoscopy, ECG, vital signs, and laboratory safety results. 6. Patients who have suffered cardiac chest pain within the last year. 7. Patients with documented damaged heart or severe / impaired kidney function or insufficiency and patients who require a low sodium diet. 8. Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia. 9. Patients who have suffered a recent, significant, unexplained weight loss of more than 7 Kg in the last 6 months. 10. Those with difficulty swallowing (dysphagia), gastrointestinal (GI) bleeding, or other symptoms suggestive of neoplastic or severe inflammatory disease within the 12 months before screening (Visit 1). 11. Patients with a history (within the last 3 months) and / or symptom profile suggestive of and / or discovered on endoscopy of the following: i. Gastric or duodenal erosions ii. Duodenitis iii. Polyps larger than 0.5 cm, or those clinically significant in the opinion of the Investigator iv. Erosive GORD (Los Angeles [LA] classification grades C-D) v. Barrett’s oesophagus vi. Acute peptic ulcer and / or ulcer complications vii. Zollinger-Ellison syndrome viii. Gastric carcinoma ix. Pyloric stenosis x. Patients who were observed on endoscopy to have a hiatus hernia with a diameter which exceeds 3cm xi. Any other clinically significant gastrointestinal disease 12. Oesophageal or gastric surgery, intestinal obstruction. 13. Current pernicious anaemia. 14. Indication for H-pylori eradication therapy. 15. Known gastro-intestinal bleeding (haematochezia or haematemesis). 16. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection. 17. Patients with severe constipation. 18. Any previous history of allergy or known intolerance to macrogol 20,000, mannitol(E421), copovidone, acesulfame K, aspartame (E951), mint flavour, carmoisine lake (E122), magnesium stearate, xylitol DC (contains carmellose sodium) or the following formulation constituents: sodium alginate, calcium carbonate, sodium bicarbonate. 19. Patients who have taken any of the below prohibited med
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets in the reduction of the symptoms of GORD as assessed using the Reflux Disease Questionnaire (RDQ).;Timepoint(s) of evaluation of this end point: Baseline vs Treatment period; Secondary Objective: The secondary objectives of this study are: - to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets in the reduction of dyspepsia in patients with GORD as assessed using the dyspepsia dimension of the RDQ. - to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets as measured by patient satisfaction - Safety and tolerability evaluation based on assessment of adverse events, vital signs and Electrocardiogram (ECG). ; Primary end point(s): The primary endpoint will be whether the patient achieves a reduction of at least 1.5 in the RDQ GORD dimension between baseline and the end of the treatment period. This will be compared between the Sodium Alginate Chewable Tablets and Matched Placebo Tablets. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline vs Treatment period; Secondary end point(s): The difference between test and placebo in: - Change from baseline at the end of the treatment period in the RDQ dyspepsia dimension score (all patients) - Patient rating of the magnitude of change in symptoms from the Overall Treatment Evaluation (OTE) at the end of the treatment period. Patient rating of the importance of the change in symptoms from the Overall Treatment Evaluation (OTE) at the end of the treatment period - Change from baseline at the end of the treatment period in the RDQ GORD dimension score - Change from baseline at the end of the treatment period in each RDQ question - Change from baseline at the end of the treatment period in the RDQ heartburn dimension score - Change from baseline at the end of the treatment period in the RDQ regurgitation dimension score - Change from baseline at the end of the treatment period in the RDQ dyspepsia dimension score (only patients with a baseline RDQ dyspepsia dimension score of at least 1) - Number of nights when the patient experienced night time symptoms Safety Endpoints will be assessed as follows: - Whether patients had an AE (overall, as well as by severity) - Whether patients had a Treatment Emergent Adverse Event (TEAE) (overall, as well as by severity and relationship to treatment) - Change in vital signs over the study - Change in haematology and biochemistry parameters over the study | — |
Countries
Germany, United Kingdom
Contacts
Public ContactStudy Specific Mailbox
Reckitt Benckiser Healthcare (UK) Limited
Outcome results
None listed