Essai comparatif, multicentrique, prospectif, randomisé, en double insu, d’efficacité et de tolérance de Météoxane® versus placebo dans la poussée douloureuse du syndrome de l'intestin irritable

aboratoires IPRAD0 个研究点开始时间: 2009年8月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1-Obtaining written informed consent.
•2- Age greater than or equal to 18 year, to 75 year old.
•3-IBS picture characterized clinically by abdominal pain (or discomfort)
•recurring at least 3 days per month for the last 3 months;
•repeated at least two days during the last week;
•in the previous 24 hours;
•listed in the previous 24 hours between 40 and 80 (including terminals) on the VAS (scale from zero to one hundred);
•having at least two of the following:
•- Abdominal pain improved by defecation,
•- Abdominal pain who's start is associated with a change of frequency of stool,
•- Abdominal pain who's start is associated with a change in form and appearance of stool.
•4- Presence of a clinical picture of IBS from at least 6 months and of less than 10 years.
•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) yes
•F.1.3.1 Number of subjects for this age range

•1-Known hypersensitivity to the product being tested or any of its components.
•2-Anxiety important scoring greater than or equal to 7 on the scale of COVI.
•3-Presence of clinical or biological signs of seriousness, particularly unintentional weight loss, rectal bleeding, anemia, signs or history of inflammatory disease, or disease of the digestive absorption.
•4-Presence of a concomitant prohibited drug.
•5-Women with more than 6 weeks of amenorrhoea
•6-Participation in a clinical trial within three months, or participation in more than three clinical trials in the 12 months preceding the expected date of inclusion.

发起方

aboratoires IPRAD