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

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-001655-38-PT
• Date of registration: 24/03/2006
• Prospective Registration: Yes
• Primary sponsor: Menarini IFR – International Division
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 07/07/2006
• Target sample size: 336
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001655-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Germany, Portugal, Spain

Key inclusion & exclusion criteria

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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Trade Name: Spasmomen
Product Name: Otilonium Bromide
Pharmaceutical Form: Tablet
INN or Proposed INN: Brometo de Otilónio
Concentration unit: mg milligram(s)
Concentration number: 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - Definition of the pattern of pharmacological effects of otilonium bromide on the other IBS symptoms
- Assessment of the impact of treatment with otilonium bromide on the patients’ quality of life
- Evaluate whether a long term treatment with otilonium bromide can have long term effects on IBS symptoms, thereby retarding symptom relapse following treatment discontinuation
- Evaluate the economic impact of the therapy
- Evaluate the safety of treatments

Main Objective: Confirm efficacy of otilonium bromide for symptom control (frequency of abdominal pain in patients with irritable bowel syndrome (IBS) in a superiority trial versus placebo.

Primary end point(s): Abdominal pain is the most frequent IBS symptom, and its frequency (independently of subjective perception of pain intensity) is easily assessable. Therefore the frequency of abdominal pain will be adopted as primary clinical endpoint. Our target will be its evaluation at the end of the treatment period versus baseline.
Frequency of abdominal pain will be quantified by a 4-level score, based on the number of pain episodes:

0 = 0 to 1 episode during the week; this will be differentiated on the diary/CRF
1 = 2 to 3 episodes during the week
2 = 4 to 7 episodes during the week
3 = 8 or more episodes during the week.

Secondary ID(s)

MeFi/04/OBR-IBS/001

2005-001655-38-BE