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)

PIERRE FABRE MEDICAMENT0 个研究点开始时间: 2008年11月6日最近更新: 2012年3月19日

适应症

试验速览

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•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

•- 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.

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