Otilonium Bromide in Irritable Bowel Syndrome – (OBIS)Double blind, randomized, parallel group, placebo-controlled study to evaluate the effect of otilonium bromide on abdominal pain and quality of life in patients with irritable bowel syndrome Barostat sub-study:Effect of otilonium bromide versus placebo on the perception of rectal distension in patients with irritable bowel syndrome (IBS).

• Conditions: Irritable Bowel Syndrome

• Registration Number: EUCTR2005-001655-38-BE
• Lead Sponsor: Menarini IFR – International Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-25
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

? Positive diagnosis for IBS according to the following symptom-based criteria (Rome II):
12 weeks or more, which need not to be consecutive, in the last 12 months of abdominal pain/discomfort that has two of the following three features:
(a) Relieved by defecation
(b) Associated with a change in frequency of stool
(c) Associated with a change in consistency of stool
? At least 2 episodes of abdominal pain for each week during the two weeks of run-in (at visit 2).

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

? Pregnant and breast-feeding women
? Simultaneous participation in another clinical trial
? Inability to maintain the conditions of the trial
? Severe psychiatric disorders
? Severe neurological disorders
? Severe heart failure, severe ischemic heart disease and severe hypertension
? Lactose intolerance
? Any clinical condition capable of causing gastrointestinal malabsorption
? Previous intestinal surgery except appendicectomy
? History of organic gastro-intestinal disease, (e.g. inflammatory bowel disease, cancer, ectopic endometriosis)
? Parasitosis infection
? Bowel obstruction
? History of the following diseases in the previous 4 months:
? Clinically symptomatic severe anaemia
? Cholestasis
? Diabetes mellitus requiring treatment with oral antidiabetics or insulin
? Severe hepatic or renal functional abnormality according to investigator’s opinion
? Any chronic use (> 2 weeks continuously) in the previous month of concomitant medication that may affect gastro-intestinal motility and function and that cannot be stopped during the trial such as: anticholinergics, prokinetics, laxatives, antidiarrhoeals, analgesics, NSAIDs, opiates, antidepressants, probiotics and drugs adjusting the microbial state. An antithrombotic treatment with low dose of aspirin is permitted.
? Clinically relevant abnormal values in the laboratory tests
? Glaucoma
? Prostatic hypertrophy
? Pyloric stenosis
? Hypersensitivity to any ingredient of the study products (otilonium bromide and/or excipients).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified