Irritable bowel syndrome
Conditions
Interventions
Trade Name: Météoxane
Pharmaceutical Form: Capsule*
INN or Proposed INN: siméticone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
INN or Proposed INN: phloro
Sponsors
Laboratoires IPRAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 : - relative decrease of « feeling of distension » intensity (VAS) - Perception of the global relief of symptoms (Likert scale) - Number of patient responding to “pain” criteria - Number of patient responding to “feeling of distension” criteria - Number of patient responding to global relief - Area under the curve for pain evolution - relative evolution of the follow-up of « feeling of distension » intensity To assess the safety ;Primary end point(s): Evolution of abdominal pain reported by patients themselves on a VAS | — |
Countries
France
Outcome results
None listed