Phase III, multicentre, double-blind, randomised, placebo-controlled, study to assess the efficacy of V0337 SO 01A suspension 10ml 4 times a day during 7 days on 2 parallel groups of patients suffering from symptoms of gastro-oesophageal reflux disease (GORD)

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Will be included patients who fulfil the following criteria:
•\- out patients of both gender aged from 18 to 60 years,
•\- suffering from GORD\-related symptoms including heartburn, and/or epigastric pain and regurgitation,
•\*for at least two weeks before the inclusion visit,
•\*and at least 2 days during the week preceding the inclusion visit,
•\*with a heartburn at least grade 3 on a 6\-point Lickert scale at the inclusion visit,
•\- able to give a written informed consent,
•\- able to understand the protocol, to accept the constraints of the study and to come to the visits,
•\- patient who, in the judgement of the investigator is likely to be compliant during the study,
•\- registered with a social security or health insurance system,

•\- GORD symptoms needing a treatment by PPI,
•\- worsening general status,
•\- history of gastro duodenal or oesophageal surgery or vagotomy,
•\- history of or severe oesophagitis (grade C or D of Los Angeles classification),
•\- history of Zollinger\-Ellison syndrome,
•\- any cardio\-vascular, renal, hepatic, gastro\-intestinal, endocrine, haematological, neuro\-psychiatric severe diseases that will not be compatible with the participation to the study in the opinion of the investigator,
•\- history of alcohol or drug abuse,
•\- renal chronic dialysis,
•\- any diet without salt,
•\- any allergy or history of allergy to one compound of the tested drugs.