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 - Local Amendment 1 - Final Version Dated 02.08.2007 - OBIS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 336

Inclusion Criteria

?Male or female patients aged over 18 years able to give the written informed consent prior to study entry
Signed and dated written informed consent prior to study entry
? 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
Women of childbearing potential without adequate contraception; medically acceptable methods are contraceptives implant (contraceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study
? Simultaneous participation in another clinical trial
? Inability to maintain the conditions of the trial
? Severe psychiatric disorders
? Severe neurological disorders
Patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
? 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).