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
- Conditions
- Irritable bowel syndrome
- Registration Number
- EUCTR2009-012393-12-FR
- Lead Sponsor
- aboratoires IPRAD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the effectiveness of Météoxane® for pain crisis of irritable bowel syndrome in comparison to placebo.;Secondary Objective: To access the efficacy on :<br>- relative decrease of « feeling of distension » intensity (VAS)<br>- Perception of the global relief of symptoms (Likert scale)<br>- Number of patient responding to pain” criteria<br>- Number of patient responding to feeling of distension” criteria<br>- Number of patient responding to global relief<br>- Area under the curve for pain evolution<br>- relative evolution of the follow-up of « feeling of distension » intensity<br><br>To assess the safety<br>;Primary end point(s): Evolution of abdominal pain reported by patients themselves on a VAS
- Secondary Outcome Measures
Name Time Method