E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
irritable colon abdominal pain |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
|
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 estimate the variation of the intension of the abdominal pain in patients suffering from IBS |
|
E.2.2 | Secondary objectives of the trial |
To evaluate - The intensity of the abdominal distension - The patient s judgement about the experimental drug. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-males and females aged 8805; 18 and 8804; 70 years -diagnosis of irritable bowel syndrome IBS based on Rome II criteria -patients who have given their free and informed consent -patients able to follow the protocol rules -patients able to understand the protocol rules and agree on them. |
|
E.4 | Principal exclusion criteria |
-patients with inflammatory bowel diseases -patients with diabetes mellitus, collagenopaties or alteration of hemopoietic or renal functionality -patients with organic diseses of the digestive system -intolerance towards any component of the experimental drug -patients with functional dyspepsia, gastroparesis,intestinal occlusion, or atonic constipation -patients with food allergy or intolerance -patients with active malignancy of any type, or history of a malignancy patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable or previously exposed to abdominal radiation therapy. -previous abdominal surgery except appendicectomy patients with esophageal, gastric or duodenal ulcer -pregnancy, planned pregnancy or lactation -inability to give a valid informed consent or to properly follow the protocol. -recent history or suspicion of alcohol abuse or drug addiction -any severe pathology that can interfere with the treatment of the trial -previous participation in this study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
worsening of the irritable colon symptomatology. |
|
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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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
| |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |