GORD-related symptoms MedDRA version: 9.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease
Conditions
Interventions
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 Propos
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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 cycles and at least 1 month after the study end (hormonal contraceptive formulations, IUD, tubal ligation status). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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. Criteria related to treatments: -treatment by H2 blocker or PPI within the 15 days preceding the inclusion visit, -treatment by antacid (including OTC drugs) or alginates within the 15 days preceding the inclusion visit, -treatment by metoclopramide or domperidone within the 3 days preceding the inclusion, -chronic treatment by NSAID within the 15 days preceding the inclusion visit, -treatment by furosemide, or tetracyclines, or digoxine, or isoniazide, or anticholinergic drugs within the month preceding the inclusion visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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);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.;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). | — |
Countries
France
Outcome results
None listed