A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment. - Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI's

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatment
Sponsor: Reckitt Benckiser Healthcare (UK) Ltd
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

November 12, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Informed consent has been obtained.
•2\.Age: \= 18 years.
•3\.Sex: male or female.
•4\.Current evidence of symptomatic GORD in accord with the Montreal definition following treatment with a proton pump inhibitor. This evidence can be based solely on symptom characteristics.
•5\.Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity\* on at least three days a week during the two 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;
•Mild: awareness of symptom but easily tolerated
•Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
•Severe: incapacitating symptom with inability to perform normal activities, including sleep
•6\.Treatment with once daily PPI for at least the previous 4 weeks at standard doses, eg, lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day.

•1\.Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger\-Ellison syndrome, systemic sclerosis, hiatus hernia (diagnostically confirmed), recent (with last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
•2\.A recent history of drug, solvent or alcohol abuse (weekly alcohol intake \= 140g or 17\.5 units).
•3\.Recent cardiac chest pain.
•4\.Recent, significant unexplained weight loss of greater than 6 kg in the last 6 months.
•5\.Gastro\-intestinal bleeding (hematochezia or hematemesis) within the last 3 months.
•6\.Non\-steroidal anti\-inflammatory drugs or other analgesics in doses that might compromise symptom recording.
•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):
•H2\-receptor antagonists
•Mucous membrane protection drugs
•Anti\-cholinesterase drugs, sucralfate or misoprostol preparations