Irritable Bowel Syndrome (IBS)
Conditions
Interventions
Trade Name: Spasmomen
Product Name: Otilonium Bromide
Pharmaceutical Form: Tablet
INN or Proposed INN: OTILONIUM BROMIDE
CAS Number: 26095-59-0
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
University Hospital Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients are those of either gender, above the age of 18, eligible to give informed consent, newly diagnosed with or newly to be treated for IBS in primary care, as this is the setting where the majority of these patients is managed. The diagnostic gold standard, in line with clinical practice, will be clinician’s diagnostic judgment. However, to support the diagnosis and make it more uniform, a Rome IV-based diagnostic questionnaire with pictograms and a list of alarm symptoms will also be included in the CRF at the initial visit, and guidance for diagnosis and potentially useful additional tests will be provided at the investigator meetings, based on the Rome IV management algorithm. Patients who did not receive treatment over the preceding 4 months, and who did not receive long-term treatment (>3 consecutive weeks) with otilonium bromide in the past are eligible for the trial. Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. 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 470 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria applies to the following points: • Patients not capable to understand or be compliant with the study. • Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease), a history of major bowel surgery (not including minimal invasive surgery such as appendectomy or cholecystectomy, but including sigmoidectomy, hemicolectomy and small bowel resections) • Patients who received treatment with otilonium bromide in the past for more than 3 weeks consecutively or who received otilonium bromide recently for any duration in the last 3 months. • Patients who have used FODMAP or NICE diet before. • Patients who recently (last 3 weeks) used other medication for IBS, or who changed their diet for IBS or for any other reason over the last 3 months. To be included in the trial patients should stop these treatments following the advice of their GP (see paragraph 8.9). • Patients with diabetes, uncontrolled thyroid disease, active malignant disease (not including patients with cancer free diagnosis for more than 5 years), symptomatic uncontrolled endometriosis. • Patients with a major psychiatric disease. The use of a single antidepressant on a stable dose for at least 3 months is allowed (see paragraph 8.9). • Patients with drug abuse and/or alcohol abuse. • Patients on pharmacologically prepared probiotic formulations (i.e. bought in the pharmacy) will be excluded. The use of probiotic drinks or yoghurts available from food stores, such as Activia®, Yakult ®, Actimel ®, is allowed but should be registered as “complementary treatment”(see paragraph 8.9). • Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. Also excluded are women of childbearing potential not using effective contraception or women planning to become pregnant the next 6 months (see paragraph 8.9 of the protocol). Methods of contraception considered highly effective are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner or sexual abstinence (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome is the improvement in IBS-Symptom Severity Score after 8 weeks of otilonium bromide compared to dietary intervention, with a 50-point drop being the established cut-off used in clinical trials. Based on our clinical experience and the available clinical data, we hypothesize that the dietary intervention will be superior to treatment with otilonium bromide 40 mg t.i.d. in improving IBS-SSS. ;Secondary Objective: As a secondary hypothesis, we propose that initial treatment with diet, compared to medication, generates less health economic costs over a 6-months follow-up period. Healthcare resource utilization (HRU) related to IBS (medical consultations, diagnostic tests, therapies, hospitalizations, management of adverse reactions) will be collected using an ad-hoc questionnaire. Retrospective HRU data will be collected at the baseline visit for up to a maximum of 6 months for direct costs and 3 months for indirect costs. Prospective HRU are collected during routine follow-up at 2, 4 and 6 months/Early Termination. At the same time points, we will also assess the impact of IBS on work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire-irritable bowel syndrome version. We will also evaluate quality of life using a syndrome-specific instrument (IBSQOL) as well as the generic EuroQol instrument. ;Primary end point(s): The primary endpoint is based on the improvement of the IBS-SSS score from baseline after 8 weeks of treatment. A responder is defined as a patient who has an improvement with 50 points or more on this validated scale after 8 weeks of treatment compared to baseline. The IBS-SSS is a validated and easy-to-use score for IBS symptom severity, and has been used in multiple international studies. The questionnaire is available in validated Dutch and French versions. The severity score is calculated as the sum of five IBS-SSS questions that are scored from 0 to 100. The baseline score serves | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are the improvement of the IBS-SSS score from baseline after 4 weeks of treatment (short term treatment response after 4 weeks is relevant for clinical practice), and at the follow-up visits of 4 and 6 months (long-term treatment outcome in terms of symptom control). The mean IBS-SSS scores will be collected at these time points to indicate magnitude of symptom improvement, taking into account that treatment modalities after 8 weeks may vary as this is then left to the discretion of the patient and the GP. ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Belgium
Contacts
Public ContactFlorencia
University Hospital Leuven
Outcome results
None listed