DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF A 4-WEEK TREATMENT WITH ORAL DOSES OF MEN15596 IN IRRITABLE BOWEL SYNDROME - ND

aboratorios Menarini S.A. - Menarini Group0 sites560 target enrollmentOctober 1, 2008

Overview

No summary available.

Registry

who.int

Start Date

October 1, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

aboratorios Menarini S.A. - Menarini Group

•1\-Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
•2\- Male or female patients aged 18 \- 70 years.
•3\- Clinical diagnosis of IBS (all subtypes of IBS\-d, IBS\-c, IBS\-m, or IBS\-u) according to the following symptom\-based criteria as per Rome III criteria:
•Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
•4\.For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before the start of run\-in period (Day \-14\).
•5\.Use of appropriate contraceptive methods throughout the entire study period and up to 30 days post\-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous six months.
•6\.Normal physical examination or without clinically relevant abnormalities.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.IBS patients having more than 3 bowel movements/day (for more than 1 day/ week) OR less than 2 bowel movements/week during the 2 week run in period.
•2\.Patients with organic abnormalities of the gastro\-intestinal tract, including history of colonic or major abdominal surgery, (appendicectomy or hysterectomy excluded), current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
•3\.History of gluten enteropathy.
•4\.Lactose intolerance as assessed by response to diet.
•5\.Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
•6\.Previous diagnosis of Diabetes Mellitus (either type 1 or 2\).
•7\.Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable from at least two months.
•8\.Major psychiatric, neurological or cardiovascular disorders.
•9\.Use of prohibited concurrent medication within 7 days prior to screening, namely:
•antimuscarinic drugs;