A multi-centre, randomised, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on symptoms of gastro-oesophageal reflux disease. - Sodium Alginate Chewable Tablet European Symptom Relief Study

Overview

No summary available.

Registry

who.int

Start Date

May 18, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 GORD dimension 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.

•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.