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Register:	EUCTR
Last refreshed on:	4 February 2013
Main ID:	EUCTR2005-001655-38-DE
Date of registration:	17/02/2009
Prospective Registration:	No
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 - Local Amendment 1 - Final Version Dated 02.08.2007 - 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 - Local Amendment 1 - Final Version Dated 02.08.2007 - OBIS
Date of first enrolment:	21/12/2007
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
Phase:

Countries of recruitment
Belgium	Germany	Portugal	Spain

Contacts

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Key inclusion & exclusion criteria

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).

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

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10023003 Term: Irritable bowel syndrome

Intervention(s)

Trade Name: SPASMOMEN 40
Product Name: Otilonium Bromide
Pharmaceutical Form: Coated tablet
INN or Proposed INN: OTILONIUM BROMIDE
CAS Number: 26095590
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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

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 Outcome(s)

Secondary ID(s)

MeFi/04/OBR-IBS/001

2005-001655-38-BE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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