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)

• Conditions: GORD-related symptoms; MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2008-002562-60-FR
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).