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)

INTERVENTION: Product Code: V0337 SO 01A Pharmaceutical Form: Oral suspension INN or Proposed INN: alginic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ INN or Proposed INN: Aluminium hydroxide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use CONDITION: GORD‐related symptoms ; MedDRA version: 9.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease PRIMARY OUTCOME: Main Objective: To assess the efficacy of repeated oral dose of V0337 SO 01A (10 ml, 4 times per day) administered during 7 days in comparison to placebo in patients suffering from symptoms of gastro‐oesophageal reflux disease (GORD) Primary end point(s): Change of heartburn intensity assessed by the patient between D1 (visit 1) and D8 (visit 2) on a 6‐point Lickert scale (none, very mild, mild, moderate, severe, very severe). Secondary Objective: To assess the safety of repeated oral dose of V0337 SO 01A (10 ml, 4 times per day) administered during 7 days in patients suffering from symptoms of gastro‐oesophageal reflux disease (GORD) in term of adverse events. INCLUSION CRITERIA: 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, ‐ in case of women of childbearing potential, she has to present a negative urinary pregnancy test at inclusion visit and currently to use an efficient contraceptive method for at least 2 menstrual cyc