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Clinical Trials/EUCTR2005-001655-38-PT
EUCTR2005-001655-38-PTActive, not recruitingNot Applicable

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 - OBIS

Menarini IFR – International Division0 sites336 target enrollmentStarted: March 24, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
336
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •? Prostatic hypertrophy
  • •? Pyloric stenosis
  • •? Hypersensitivity to any ingredient of the study products (otilonium bromide and/or excipients).

Investigators

Sponsor
Menarini IFR – International Division

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