irritable colon abdominal pain MedDRA version: 6.1 Level: PT Classification code 10023003
Conditions
Interventions
Pharmaceutical Form: Gastro-resistant capsule, soft
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Pharmaceutical form of the placebo: Gastro-resistant capsule
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the variation of the intension of the abdominal pain in patients suffering from IBS;Secondary Objective: To evaluate - The intensity of the abdominal distension - The patient s judgement about the experimental drug.;Primary end point(s): worsening of the irritable colon symptomatology. | — |
Countries
Italy
Outcome results
None listed