E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the effectiveness of Météoxane® for pain crisis of irritable bowel syndrome in comparison to placebo. |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of abdominal pain reported by patients themselves on a VAS |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |