A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled pivotal study to assess the effect of a sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment. - Sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to PPI

Reckitt Benckiser Healthcare (UK) Limited0 sites396 target enrollmentOctober 28, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2014

End Date

December 24, 2015

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Informed consent has been obtained.
•2\. Age: Minimum 18 years
•3\. Sex: male or female.
•4\. Current evidence of symptomatic GORD in accordance with the Montreal definition(5\) following treatment with a proton pump inhibitor (as specified in inclusion criteria \#6\). This evidence can be based solely on symptom characteristics but in the opinion of the Investigator the symptoms are not related to conditions such as irritable bowel syndrome, gall bladder disease or other such conditions that may present themselves as heartburn or regurgitation.
•5\. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity\* on at least 3 days a week during the 2 weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms.
•\*Symptom intensity should be assessed using the following scale:
•a. Mild: Awareness of symptom but easily tolerated.
•b. Moderate: Discomforting symptom sufficient to cause interference with normal activities including sleep.
•c. Severe: Incapacitating symptom with inability to perform normal activities, including sleep.
•6\. Prescribed treatment with once\-daily (before breakfast) PPI for at least the previous 4 weeks at stable standard approved doses, e.g. lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day, 40 mg esomeprazole per day.

•Patients to whom any of the following conditions apply must be excluded:
•1\.Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger\-Ellison syndrome, systemic sclerosis, recent (within the last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
•2\.A recent (previous 3 months) history of drug, solvent or alcohol abuse (weekly alcohol intake \=140 g or 17\.5 units).
•3\.Recent (previous 3 months) cardiac chest pain.
•4\.Recent (previous 6 months) significant unexplained weight loss of \>6 kg in the last 6 months
•5\.Gastrointestinal bleeding (lower GI bleeding or haematemesis) within the last 3 months.
•6\.Patients who have taken non\-steroidal anti\-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) for more than 3 consecutive days in the 28 days prior to screening
•7\.Patients who have taken any of the following treatments in the week prior to the screening visit (Visit 1\) and who may require any of these during the study (as they are also excluded throughout the study):
•a.H2\-receptor antagonists
•b.Anti\-cholinesterase drugs, sucralfate or misoprostol preparations